Podcasts about QMS

Every once in a while, I sit down with a guest who reminds me exactly why I started this podcast in the first place. That was the case with Kelly Denison, the second-generation owner of Continental Machine Company in Albuquerque, New Mexico. Kelly is the kind of leader who sees his machine shop not just as a business—but as a vehicle for opportunity, growth, and purpose. In our conversation, we talked about what it means to carry forward a legacy. Kelly's dad bought the business in 2000, and by 2020, Kelly had earned his way into full ownership—not by entitlement, but by doing every job in the shop. From janitor to programmer to accountant, he worked his way up and built a deep understanding of what it takes to run a shop. But what struck me most was his mindset. Kelly isn't just making precision parts—he's making machinists. He's building careers, instilling pride, and leading with heart. From funding a church in Costa Rica to mentoring his team toward mastery, Kelly is proving that shop ownership can be both profitable and profoundly meaningful. If you've ever wrestled with succession, struggled with ISO as a “quality burden,” or wondered how to build a values-driven culture that retains talent, this episode is for you. It's packed with humility, honesty, and hard-earned wisdom. I walked away inspired—and I know you will too. You will want to hear this episode if you are interested in... (0:00) Why shop owners are part of a special brotherhood (0:10) Grow your top and bottom line with CLA (1:22) Reflecting on my conversation with Kelly (3:46) The history of Continental Machine (and Kelly's role) (6:20) Overview of today's team and customer base (8:00) Building out ISO and shifting to a true business system (11:50) Why five-axis milling transformed their workflow (14:24) Turning a QMS into a business-wide tool (18:27) Why shop owners shouldn't try to do it all alone (20:00) Lessons from a diverse mastermind group (23:34) The myth of the technician-turned-entrepreneur (24:53) Kelly's side business and what it taught him about ownership (26:56) Stay tuned for Top Shops 2025 registration! (29:21) Recruiting through trade schools and investing in people/career growth (33:30) The mindset shift from making parts to making machinists (35:19) Kelly's “why” and the role of faith and philanthropy (37:15) Making parts that save lives—and being proud of it (40:57) Navigating the emotional side of family business succession (45:38) Kelly's proudest moment: building components for defense systems (49:00) Final reflections on pride, purpose, and what it means to lead a shop (50:25) Three reasons to check out Buy the Numbers Resources & People Mentioned The E-Myth Revisited Grow your top and bottom line with CLA Stay tuned for Top Shops 2025 registration! Connect with Kelly Denison Continental Machining Company Connect with Kelly on LinkedIn Connect With Machine Shop Mastery The website LinkedIn YouTube Instagram   Subscribe to Machine Shop Mastery on Apple, Spotify Audio Production and Show Notes by - PODCAST FAST TRACK

In this episode of the Global Medical Device Podcast, Etienne Nichols sits down with seasoned MedTech founder and investor Jon Bergsteinsson to unpack a critical—but often overlooked—topic: budgeting in early-stage medical device startups. Drawing from his deep regulatory, clinical, and investment experience, Jon shares the red flags investors look for, the cost categories that founders routinely miss, and why a line item called “compliance” just doesn't cut it. Whether you're a startup founder, a regulatory lead, or a project manager, this episode offers a sharp lens into the financial planning realities that can make or break product development and commercialization in MedTech.Key Timestamps02:34 – Why QMS, regulatory, and clinical are budget afterthoughts for startups06:45 – What separates experienced vs. inexperienced MedTech founders in budgeting10:20 – Why software and compliance tools get left out of early budgets14:12 – How missing budget detail impacts product quality and time-to-market19:04 – Red flags investors look for in MedTech startup budgets23:30 – How to improve budgeting accuracy without a CFO28:10 – Critical cost categories MedTech founders often overlook35:55 – Advice for recovering from a budgeting oversight39:40 – Comprehensive checklist of overlooked line items (manual translation, UDI, ISO licenses, and more)45:00 – Final advice: why networking trumps isolation for smarter budgetingStandout Quotes"Relying on the status quo is never good. There are always ways to do things better."Jon reminds founders and compliance professionals alike that innovation doesn't stop at the product level—it also applies to budgeting, systems, and team empowerment."Getting a 510(k) through is just the starting point. Budgeting like everything ends there is a massive red flag."This quote highlights the investor's perspective on sustainability and long-term thinking—crucial traits in any fundable founder.Key TakeawaysBroad Budget Buckets Signal InexperienceLumping all compliance-related costs under one line item may look tidy but signals to investors a lack of operational depth. Break out line items for QMS, clinical, regulatory, and software tools.Software and Tools Are Not Optional ExtrasFounders must factor in essential systems—like eQMS, CAD, risk management, and clinical data tools—early in budgeting. Assuming a single hire covers everything is a critical mistake.Budgets Must Reflect Time and Scale RealisticallyFlat budgets over 2–3 years, or those that assume regulatory costs end at market clearance, raise red flags. Investors expect dynamic budgeting that reflects the realities of growth, post-market surveillance, and team evolution.Outsourcing ≠ All-InclusiveMany startups underestimate the actual costs tied to consultants and CROs, assuming “someone else is handling it.” Always clarify what's included—and what's not.Recovery Is Possible—If You Own ItIf your budget's off-track, clear communication with your board and investors, a willingness to revise, and a plan for worst-case scenarios are your best tools for regaining credibility.ReferencesJon Bergsteinsson on LinkedInEtienne Nichols on LinkedInGreenlight Guru – QMS and Clinical platform for MedTech companiesMedTech...

In this live episode from the LSI conference in California, Etienne Nichols is joined by Ashkon Rasooli to break down what it really takes to build a high-performing quality management system (QMS) in medtech—from startup chaos to post-market scale. Ashkon shares a phased approach to aligning QMS implementation with product development, explains the concept of "enforcement points," and reveals how founders can reduce the burden of compliance by starting small and planning ahead. If you're navigating regulatory requirements while trying to stay innovative, this episode is your roadmap to smarter, leaner quality.Key Timestamps00:02 – Introduction to Greenlight Guru and medtech process integration01:15 – QMS evolution from startup to commercialization03:00 – Phase-based product development overview (Phases 0–6)06:35 – Why QMS should follow product needs, not just regulatory triggers09:10 – Agile vs. proceduralism in quality systems11:50 – Building a quality culture during the feasibility phase15:25 – When to implement QMS controls and how to prepare for “enforcement points”18:40 – Investor-driven and regulatory QMS triggers21:10 – How early QMS planning saves time and reduces future remediation26:20 – Ashkon's final advice for startups: start small and stay proactiveStandout Quotes"You've got to take the BS—being burdensome—out of QMS."Ashkon Rasooli redefines QMS as a project management tool, challenging the notion that compliance must be a burden. This quote encapsulates his philosophy of proactive, phased implementation that actually enhances product development."Start small and do a little bit at a time—it won't seem like a burden."A practical mantra for startups, this advice underscores how a gradual, well-aligned QMS rollout can prevent last-minute fire drills and wasted effort.Top TakeawaysUse the "Phase 0–6" Model to Guide QMS Rollout – Align QMS implementation with the stages of product development to ensure each step supports the next.Don't Wait for Enforcement Points – Start building your QMS before regulators or investors demand it to avoid remediation-heavy implementations.Prioritize Culture Before Controls – In early feasibility, focus on aligning your team with medtech's safety responsibilities, rather than formal procedures.Procedures Should Support Outcomes, Not Just Check Boxes – Avoid proceduralism by tying every process back to its intended quality objective.Regulatory Strategy = Investor Strategy – QMS maturity is increasingly scrutinized during due diligence. Treat it as a value driver, not just a cost.ReferencesAshkon Rasooli on LinkedInGreenlight Guru – Quality management software for medical devicesEtienne Nichols on LinkedIn – Connect with the hostISO 13485 vs. ISO 9001 – Explains how medical device quality systems build on general standardsISO 14155 Overview – Relevant for clinical validation proceduresMedTech 101: What Are “Enforcement Points”?In the context of QMS, enforcement points are moments when external stakeholders (regulators or investors) require proof of formalized processes. Think of it like a driver's license checkpoint—you may be cruising just fine, but at that moment, you must prove you're compliant. The earlier you prep for them, the smoother your...

Along with our regular monthly updates on policy, cereals, beef, sheep and milk, in this edition we also have a spotlight on farm business diversification. Show Notes 00:33 News in Brief 05:08 Policy Briefs – Programme for Government 2025-2026, 2025 Climate Change Committee Report, Next Generation Farming – Apprenticeships, Bluetongue (BTV) Virus Vaccine, Scottish Upland Sheep Support Scheme (SUSSS), Key Dates. 15:33 Cereals – Global Supply Risks Mount, Demand-Side Developments, Malting Barley & Feed Barley, Rapeseed Mixed Market, Oats, Overall Outlook. 22:13 Beef – Young bull numbers impacting on prices, Strong demand for manufacturing beef, Store Cattle Trade Back, Room for more? 29:02 Sheep – UK EU Strategic Partnership, Sheep Trade, Export Market, Protein Consumption 33:18 Milk – Production data, Farm-gate prices, Dairy commodities and market indicators, Antimicrobial resistance in calves, Rabobank global outlook  39:22 Sector focus – Farm Diversification. 51:05 Further articles – Croft Diversification, Reducing Antimicrobial Use in Scottish Dairy Farms, A couple more cows per herd each year would realise Scotland's economic potential by 2030, Grain Marketing Podcast, Bluetongue, Bee Health Awareness Day FAS Resources: Newsletters - Business & Policy Edition - FAS Other Links: The Natural Environment (Scotland) Bill The Land Reform (Scotland) Bill Scotland's Carbon Budgets Report 2025 Lantra Scotland - land based pre-apprenticeship scotland@lantra.co.uk Report your use of the bluetongue serotype 3 (BTV-3) vaccine - GOV.UK GOV.uk - Bluetongue: news, information and guidance for livestock keepers GOV.WALES The Scottish Government - gov.scot QMS article: two more cows per herd per year The Cargill 2025 Protein Profile Report Scottish Farm Business Income: Annual Estimates for 2023-2024

Send us a textHere is a link to all episodes of QMS's podcast https://qmscotland.co.uk/news-media/qms-podcast

This week's guest is Bob Buhlmann (https://www.linkedin.com/in/bob-buhlmann-4182244/), Head of Quality Digital and Computer Strategy at AstraZeneca. Bob shares how technology has evolved over the course of his 35+ years in the pharma industry, the hurdles pharma companies often face when adopting emerging technology, and the future of quality management. He also takes a deep dive into validation, the challenges associated with validating software created by citizen developers, and AstraZeneca's innovative solution for this pressing problem in the pharma industry. Augmented Ops is a podcast for industrial leaders, citizen developers, shop floor operators, and anyone else that cares about what the future of frontline operations will look like across industries. This show is presented by Tulip (https://tulip.co/), the Frontline Operations Platform. You can find more from us at Tulip.co/podcast (https://tulip.co/podcast) or by following the show on LinkedIn (https://www.linkedin.com/company/augmentedpod/). Special Guest: Bob Buhlmann.

In this episode, Carmen Bellebna will share with us the journey of deepeye Medical to implement the EU AI act requirements in parallel with the EU MDR certification. We will review first what is the AI ACT for those that are still not aware and also all the challenges that deepeye went through to be able to get the EU MDR certification.  Who is Carmen Bellebna?  Carmen Bellebna is a Regulatory Affairs and Quality Management expert at deepeye Medical, a medtech company pioneering AI-driven solutions for ophthalmology. With a strong background in implementing EU regulatory frameworks, Carmen has been closely following the evolution of the Artificial Intelligence Act (AI Act) and its intersection with the Medical Device Regulation (MDR). She has played a key role in integrating AI-specific compliance strategies into deepeye's QMS, ensuring alignment with both MDR and upcoming AI requirements. Carmen recently delivered a well-received presentation at the Outsourcing in Clinical Trials (OCT) conference in Munich, where she shared hands-on insights and practical tips for operationalizing AIA obligations within a regulated medtech environment.     Who is Monir El Azzouzi?  Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.  Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.  Link Carmen Bellebna LinkedIn:  https://www.linkedin.com/in/men-be-a1828a81/   Social Media to follow Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice Authorized Representative and Importer services:https://easymedicaldevice.com/authorised-representative-and-importer/ 

When you're launching or scaling a machine shop, it's easy to think of software as a cost—something you "have to have" just to get by. But what if your tech stack could become your sharpest competitive edge?  In this episode of the Machine Shop MBA series, we are joined by returning guest and digital strategy expert Bryce Barnes to unpack why your software decisions might matter more than your next CNC machine purchase. They explore how an intentional, integrated digital backbone isn't just for managing data—it's about accelerating sales, boosting throughput, and future-proofing your shop. We share our own journeys with building digital infrastructure from scratch, transitioning off spreadsheets, and how we now see our systems as a key part of our brand. The reality is, when your systems are dialed in, they don't just save time—they win work. We've seen it ourselves: customers are more confident, audits are smoother, and top talent is easier to attract when you run a modern, connected operation. We break down the key components of a modern machine shop's digital ecosystem—from ERP and QMS to CAD/CAM, CRM, and even the email domain you choose when naming your business. We explain how integrations reduce risk and waste, why starting early simplifies everything later, and how a great tech stack not only saves time but wins customers. Whether you're quoting parts on an Excel sheet, trying to choose your first ERP, or just curious how cloud, AI, and machine monitoring can fit into your daily operations, this episode is an essential listen. It's not a tech tutorial—it's a business strategy conversation every shop owner needs to hear. The takeaway? Don't tack on software as an afterthought. Build your shop around it. Segments (0:00) Broken spreadsheets and the hidden dangers of quoting errors (0:35) Let ProShop ERP help you achieve on-time delivery  (2:10) Why the MBA series is resonating with startup shop owners (3:26) From machines to mindsets: introducing the digital backbone (5:32) What a tech stack actually includes (and why it matters early) (6:48) How shops can and should go paperless (8:29) Email addresses, domains, and the perception of professionalism (9:10) Tech stack mindset: cost center vs. competitive advantage (13:21) CRM, marketing, and quoting: connecting the whole flow (16:54) The case for seamless data flow and integration (18:10) Human input, machine monitoring, and minimizing mistakes (20:11) Designing your workflows digitally, not retrofitting after (21:35) The value of ERP systems built specifically for machine shops (25:58) Grow your top and bottom line with CLA (27:42) A jaw-dropping machine monitoring story from aerospace (29:45) Where to start with scale: communications and safety (32:40) Matching tech stack to business model (high-mix vs. high-volume) (35:02) Involving your team in tech decisions increases buy-in and success (36:13) Choosing tools with a strong community and support ecosystem (39:00) Pros and cons of cloud infrastructure for manufacturers (43:30) The hidden cost of old tech: attracting and retaining talent (46:30) Getting IT help doesn't mean hiring full-time staff (47:00) A lean and logical order to build your tech stack from day one (50:00) Don't forget cybersecurity—it's essential, not optional (51:40) Why early investment pays off more than late retrofitting (53:00) Your tech stack is also your sales pitch (54:00) The virtuous cycle of the right tools: fewer mistakes, more wins (55:35) What's next: Building your brand and growing your sales  Resources mentioned on this episode Tech Stack Checklist  Your 6-Step Guide to Achieving Over 95% On-Time Delivery ProShop ERP Paperless Parts Grow your top and bottom line with CLA Quickbooks Xero Connect With MakingChips www.MakingChips.com On Facebook On LinkedIn On Instagram On Twitter On YouTube

Send us a textIn this episode, we're joined by RNAS President as we look ahead to the very first Beef Tech event, hosted on 28th May at Home Farm, Kininmonth, Peterhead – a new event showcasing innovation and technology in the beef sector.We also catch up with QMS Chair Kate Rowell, who shares reflections on lambing and calving season, the challenges and rewards of this busy time of year, and how the recent good weather is helping farmers across the country.And as always, Iain Macdonald brings his expert insight into current market trends and prices, giving you the latest on livestock and trade developments.It's a packed episode full of practical insight, forward-thinking ideas, and a look at what's driving change in Scottish agriculture.Follow us on social media and join the conversation!Here is a link to all episodes of QMS's podcast https://qmscotland.co.uk/news-media/qms-podcast

Data drives improvement in business, and healthcare is no exception. With the effective use of a quality management system (QMS), Sterile Processing (SP) professionals can use data they already collect, including sterilizer printouts and biological monitoring, to improve processes and make their work more efficient and accurate. In episode 126, host Casey Czarnowski speaks with Hannah Schroeder of Pure Processing about QMS in the Sterile Processing department (SPD). Schroeder provides a high-level introduction to the QMS process. She discusses its key components, ways to incorporate a QMS in various areas of the SPD, relevant standards and guidelines, and diverse strategies for measuring QMS effectiveness. Listen to learn how a QMS can reveal trends and help SP leaders advocate for resources, such as additional staff, equipment or space. Hannah Schroeder, Clinical Education Specialist, Pure Processing In her current role, Hannah Schroeder brings her passion and experience in sterile processing to the forefront. Schroeder began as a technician in 2017 and became an education coordinator after progressing through various, advancing roles. Her expertise covers areas such as process improvement, recruitment, education and construction project management. She strives to raise awareness and advocate for the needs and education of professionals in the instrument reprocessing profession. Sponsored by Pure Processing Pure Processing is an innovator and manufacturer of sterile processing and endoscope reprocessing technologies. The company focuses on ergonomic solutions that support SPD and GI teams in their effort to keep patients safe. By collaborating with customers and maintaining a deep understanding of industry standards and guidelines, Pure Processing develops solutions truly designed to meet the unique needs that come with instrument and endoscope reprocessing. Earn CE Now

Feeling overwhelmed by all the new compliance changes?

This week's guest is Jim Fox (https://www.linkedin.com/in/james-s-fox/), SVP of Americas Supply Operations at AstraZeneca. Jim explains how digital manufacturing in pharma has evolved over his nearly 3 decades in the industry, from basic automation and data collection to advanced predictive modeling and integrated digital ecosystems—and why having humans in-the-loop continues to be critical despite these advancements in autonomy. He also shares his perspective on building trust in emerging technology, the continued importance of lean principles, and the tension between regulation and speed to market. Augmented Ops is a podcast for industrial leaders, citizen developers, shop floor operators, and anyone else that cares about what the future of frontline operations will look like across industries. This show is presented by Tulip (https://tulip.co/), the Frontline Operations Platform. You can find more from us at Tulip.co/podcast (https://tulip.co/podcast) or by following the show on LinkedIn (https://www.linkedin.com/company/augmentedpod/). Special Guest: Jim Fox.

In this episode of The Quality Hub, Chatting with ISO Experts, host Xavier Francis is joined once again by Norm Verbeck, consultant from Core Business Solutions, to dive into how ISO 9001 (QMS) and ISO 14001 (EMS) align and complement each other. They discuss the key similarities between the two standards, including shared requirements like management reviews, internal audits, corrective actions, and more. Norm explains how organizations can integrate these systems to streamline processes, which can save time and. The conversation also highlights how quality risk assessments can uncover environmental concerns, potentially guiding companies toward ISO 14001 compliance or certification. With practical examples and real-world insights, this episode is a must-listen for companies looking to enhance operational efficiency and environmental responsibility.   Helpful Resources: How is ISO 9001 Implemented?:  https://www.thecoresolution.com/how-is-iso-9001-implemented For All Things ISO 9001:2015: https://www.thecoresolution.com/iso-9001-2015 Contact us at 866.354.0300 or email us at info@thecoresolution.com A Plethora of Articles: https://www.thecoresolution.com/free-learning-resources ISO 9001 Consulting: https://www.thecoresolution.com/iso-consulting

In this episode of the Global Medical Device Podcast, Etienne Nichols speaks with renowned regulatory and reimbursement expert Karandeep Singh Badwal to uncover the complexities of medical device reimbursement across the US, EU, and Asian markets. From the influence of governmental systems to the nuances of coding, coverage, and payments, Karandeep shares real-world insights for MedTech companies developing their global market strategies. Learn why early planning for reimbursement is just as crucial as regulatory approval, and how future-proofing your strategy against political and economic changes can safeguard your device's success.Key Timestamps:00:00 – Intro and Sponsor Message (Greenlight Guru Quality)02:30 – Why Reimbursement Must Be Considered Early07:15 – US Reimbursement System: Medicare, Medicaid, and Private Insurers13:10 – EU Reimbursement: Challenges with Fragmented National Systems17:45 – Asian Market Differences: Japan, China, and South Korea23:20 – The Importance of a Reimbursement Expert28:05 – Navigating Political Changes in Global MedTech Markets33:30 – Special Challenges for AI and Software as a Medical Device40:00 – Direct-to-Consumer vs. Prescription Strategies46:20 – Integrating Real-World Evidence and Post-Market Surveillance52:00 – How Management Reviews Can Align Business and Quality Goals01:03:10 – Pros and Cons: US vs. EU Reimbursement Models01:18:20 – Final Takeaways and Closing ThoughtsStandout Quotes:"Reimbursement isn't just the final step after regulatory approval — it is a core business strategy."Why it matters: Many companies fail by not building reimbursement into their earliest development and design decisions."You can have the most innovative medical device in the world, but without a reimbursement pathway, you won't have a viable business."Why it matters: Innovation alone isn't enough; financial strategy is crucial to survival and growth.Top Takeaways:Start with reimbursement in mind: Align your product claims, indications, and market strategies with potential reimbursement pathways early.Tailor by region: US, EU, and Asian markets all have distinct reimbursement landscapes — success in one doesn't guarantee success in another.Hire jurisdiction-specific experts: Use consultants experienced in your target markets to avoid costly mistakes.Leverage post-market surveillance: Integrate real-world evidence gathering into your QMS and management reviews to support reimbursement claims.Build strategic flexibility: Political and regulatory landscapes shift — maintain backup jurisdictions and alternative market strategies.References:Etienne Nichols on LinkedInGreenlight Guru Quality Management SystemMedtech Podcast hosted by Karandeep Singh BadwalMedTech 101 Section:What is "Reimbursement" in MedTech?Reimbursement refers to how a company gets paid for a medical device after it's cleared for use. This usually involves navigating government programs (like Medicare) or private insurance, and it determines how easily hospitals, clinics, or individuals can buy and use a product.Simple Analogy: Think of it like getting a movie produced: regulatory clearance is getting your movie rated, but reimbursement is making sure theaters agree to pay you to...

This week's guest is Joel Fidalgo (https://www.linkedin.com/in/joel-fidalgo-7b6347121/), CIO of NextPharma. Joel shares how NextPharma is bridging IT and operations to lead digital transformation across a decentralized CDMO network, and taking a modular, app-based approach to MES and eBR. He also explores the changing role of the CIO in driving innovation on the shop floor, the importance of cross-functional collaboration, and the challenges of scaling standardized solutions across diverse sites each of which have their own unique requirements. Augmented Ops is a podcast for industrial leaders, citizen developers, shop floor operators, and anyone else that cares about what the future of frontline operations will look like across industries. This show is presented by Tulip (https://tulip.co/), the Frontline Operations Platform. You can find more from us at Tulip.co/podcast (https://tulip.co/podcast) or by following the show on LinkedIn (https://www.linkedin.com/company/augmentedpod/). Special Guest: Joel Fidalgo.

Documentation Hierarchy and Best Practices in Quality Systems with Aaron SnyderIn this episode of Let's Combinate, host Subhi Saadeh is joined by Aaron Snyder, the creator of Quality Systems Explained and a seasoned consultant in regulated quality systems. The discussion revolves around the critical role of documentation in quality systems, which serves as the backbone of compliance. Key topics include the hierarchy of regulations, document management best practices, the intricacies of quality manuals, and the critical distinctions between SOPs and work instructions. Additionally, they explore the interconnectedness of document control and training, emphasizing the importance of defined roles and responsibilities within organizations. Listeners are provided with insights into establishing and maintaining effective documentation systems while ensuring adherence to regulatory requirements.00:00 Introduction and Guest Introduction00:37 The Importance of Documentation in Quality Systems01:30 Hierarchy and Structure of Documentation02:44 Standard Operating Procedures (SOPs) vs. Work Instructions11:22 Document Control and Change Management15:52 Roles and Responsibilities in Quality Systems18:20 RACI Matrix and Its Importance20:47 Common Issues in Documentation and Training25:25 Conclusion and Where to Find More InformationAaron Snyder is a quality management systems expert and the founder of Quality Systems Explained. He previously served as VP of QA at Allotex and has held roles at Fresenius Kabi, Molnlycke, Waters Corporation, Covidien, Cardinal Health, and General Electric. With extensive experience across pharmaceuticals, medical devices, and combination products, Aaron is also a member of the AAMI Faculty, teaching several courses on various QMS topics. An avid content creator, he dissects, presents, and teaches QMS and cGMP topics on his YouTube channel, Quality Systems Explained.Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

In our 400th episode of the Global Medical Device Podcast, host Etienne Nichols is joined by Greenlight Guru's Sara Adams to unpack the findings of the 2025 Medical Device Industry Benchmark Report. From the rise of family office investments to QMS upgrades and the impact of regulatory uncertainty, this episode delivers a candid and comprehensive look at the current MedTech landscape. Sara brings her quality expertise and industry anecdotes to life, while Etienne adds sharp insights on strategic planning and product development.Whether you're facing supply chain complexity, preparing for QMSR, or trying to navigate market shifts, this episode is your roadmap for the year ahead.Key Timestamps00:03 – Introduction to the 2025 Medical Device Industry Report05:00 – Market growth outlook: $800B by 203009:40 – Family office investment trends in MedTech13:15 – Hiring freezes and headcount reductions: what's behind the numbers?20:22 – Supply chain challenges and supplier qualification issues28:35 – Why only 11% of companies rate their supply chain management as “excellent”33:30 – QMS upgrades and the strategic focus on quality systems39:00 – Fundraising and clinical trials: top priorities for pre-commercial companies44:55 – Regulatory complexity: QMSR, EU MDR, and FDA staffing pressures53:50 – FDA Form 483s: top causes and how to avoid them1:04:00 – Action plan for 2025: technology, collaboration, and performance1:12:00 – Making quality your competitive edgeMemorable Quotes“Money is the air companies breathe, but safety is the ground they walk on.” – Etienne Nichols“If you're not reaching out to your FDA review team, you're already behind.” – Sara Adams“Dig the well before you're thirsty — especially in MedTech.” – Etienne Nichols

Logiciel dans l'industrie pharma : et si on parlait vraiment du processus ? On vous a déjà demandé votre avis sur la conception ou la validation d'un logiciel dans l'industrie pharmaceutique ? Vous avez participé au déploiement d'un nouveau logiciel ? À la rédaction d'un URS ? À une montée de version ? ERP, LIMS, QMS... ? Moi, oui. Plusieurs fois. Et à chaque fois… j'ai été un peu déçu.

Today we welcome Alix Ritchie onto the R2Kast!

Send us a textIn this month's episode of the QMS Red Meat Podcast, we're joined by Mairi Gougeon MSP, Cabinet Secretary for Rural Affairs, Land Reform and Islands, for an exclusive deep dive into the latest Scottish Government policies impacting the industry.We'll discuss:✅ The future of Scotland's red meat sector amidst evolving agricultural policies✅ Government strategies to support farmers, butchers, and processors✅ Balancing food security, biodiversity, and climate goals✅ The challenges and opportunities for the sector over the next five years✅ What makes Scotch Beef, Scotch Lamb, and Specially Selected Pork stand out globallyWe also get a personal insight from the Cabinet Secretary on her favourite Scottish red meat dish!Plus, we'll hear updates from Sarah Millar on industry developments and Iain Macdonald on the latest market trends across cattle, sheep, and pig sectors.Don't forget to subscribe for more expert discussions each month!

Four’N Twenty pies are literally baked-in to footy and Patties Food Group marketing boss Anand Surujpal gets a related proposition across his desk every week. But his challenge is to grow share through new buyers beyond “diehard footy fans” and tradies. So when the prop for the Paris Olympics landed, Surujpal saw an opportunity for a bigger demographic slice of the action by mashing live Olympics content with ads in real-time via QMS’ digital out of home network. The results were meaty: “When the campaign went live, we had unit sales lifts of up to 30 per cent,” says Surujpal. “This is on a big brand with distribution, awareness, trial, recognition.” Even better, “We've actually retained the consumers and maintained the growth … It’s had a big halo effect.” Strategy chief Christian Zavecz says QMS wanted to match Australia’s athletes in “pushing the boundaries of what can be achieved” while “bringing big brands and Australians together through the unifying power of sport”. Plus, the Olympics provided the perfect platform to prove digital out-of-home is now a broadcast medium that can deliver real-time creative responses – and results. So QMS, TBWA and Patties Food Group pulled out all the stops to make it happen. “We had a 24/7 newsroom that worked really closely with our tech team. We had a custom-built dynamic content optimisation platform that enabled us to continually publish real-time branded content featuring everything from medal moments to breaking news and live metal tallies, along with what to watch coming up,” says Zavecz. The results speak for themselves – Surujpal admits it’s opened his eyes to just how far digital out-of-home has advanced. “It has changed my perception of the medium. To have speed and accuracy, being relevant immediately, I think that's a powerful tool.” QMS now has the Milano Cortina Winter Olympics just around the corner.See omnystudio.com/listener for privacy information.

Änderungen an bestehenden Produkten sind notwendig. Wir sollten diese Änderungen allerdings auch entsprechend dokumentieren. Inhalt der Folge: * Entwicklung * Produktion * QMS Trage Dich auch gerne in meinen Newsletter ein. Du findest eine Möglichkeit auf der Webseite zu dieser Folge. Der Beitrag IF228 – Dokumentation von Änderungen erschien zuerst auf Ingenieurbüro David C. Kirchner.

Send us a textIn this month's episode of the QMS Red Meat Podcast, we catch up with Martin Kennedy to reflect on his time as President of NFU Scotland. He shares the highlights and defining moments of his presidency, offering valuable insights into the challenges and opportunities faced by Scottish agriculture.We also hear from Kate Rowell, who updates us on her work with the development of industry-led groups and their role in shaping the future of farming.Abby Tong brings positive news from the red meat sector, discussing the growing importance of provenance and quality in the food service industry and what it means for producers meeting consumer demands.Tune in for an insightful episode on the future of Scottish agriculture and the opportunities ahead!Here is a link to all episodes of QMS's podcast https://qmscotland.co.uk/news-media/qms-podcast

Opening reference to 'The Shopping Conspiracy' as shown on Netflix. Then we cover another CargoHub product - QMS all around adding value to the Air Cargo Product and ensuring compliance oversight.

In this episode of Let's Combinate, host Subhi Saadeh is joined by quality systems expert Aaron Snyder to explore the critical quality system element known as CAPA (Corrective and Preventive Action). They dive into the differences between CAPA approaches in the pharmaceutical and MedTech industries, examining their historical and regulatory contexts. Aaron explains how U.S. regulations describe deviations on the pharma side and non-conforming products on the MedTech side, and how these are handled differently under respective quality systems. The conversation also touches on topics like root cause analysis, verification of effectiveness, and the importance of management support in making CAPA systems effective. Aaron highlights the value of continuous improvement and debunks common misconceptions about CAPA in both industries.00:00 Introduction and Guest Introduction00:33 Understanding CAPA in Pharma and MedTech01:08 Regulatory Differences and Their Implications03:12 Event Handling and Investigation Processes08:13 CAPA System Effectiveness13:57 Quality System Approaches in Pharma and MedTech26:22 Root Cause Analysis and Continuous Improvement30:43 Conclusion and Contact InformationAaron Snyder is a quality management systems expert and the founder of Quality Systems Explained. He previously served as VP of QA at Allotex and has held roles at Fresenius Kabi, Molnlycke, Waters Corporation, Covidien, Cardinal Health, and General Electric. With extensive experience across pharmaceuticals, medical devices, and combination products, Aaron is also a member of the AAMI Faculty, teaching several courses on various QMS topics. An avid content creator, he dissects, presents, and teaches QMS and cGMP topics on his YouTube channel, Quality Systems Explained.Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

Send us a textIn this episode of the QMS Red Meat Podcast, we welcome James Withers, a seasoned expert in economic development, strategy, skills, public affairs, and communications. With a distinguished career in agri-food, drink, and tourism, James offers an invaluable perspective on the UK Farm Assurance Review.James breaks down the key findings of the report, highlighting how farm assurance systems are evolving across the UK and how they impact farmers. This episode also dives into how farmers can collaborate on common issues and best practices to improve the industry. Whether you're a farmer, business leader, or stakeholder, this episode offers valuable insights into the future of farm assurance and the role it plays in shaping UK agriculture.Here is a link to all episodes of QMS's podcast https://qmscotland.co.uk/news-media/qms-podcast

In this episode, Mark Rogovoi will share his experience with Certification bodies. He had the experience working for them and working for manufacturers so this is really something that can show you the inside. You will see the good of working with them but also the bad. Mark will be really honest and share some stories, and you'll see that this is not all good.  Who is Mark Rogovoi?  Mark Rogovoi brings 18 years of international experience in Manufacturing Quality across Poland, Russia, Kazakhstan, Spain, and Israel. He is a seasoned QMS professional proficient in ISO 9001 and ISO TS 16949 standards, with a strong Lean 6 Sigma background as a certified Green Belt. As a Lead Auditor for ISO 9001, he has conducted both internal and external audits. Mark also holds an EMBA from the Stockholm School of Economics and a master's degree in Electrotechnical Engineering from Saint-Petersburg State Electrotechnical University.  Who is Monir El Azzouzi?  Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.  Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.  Link Mark Rogovoi LinkedIn: https://www.linkedin.com/in/markrogovoi/  Social Media to follow Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice

On this episode of the Quality Hub Podcast hosted by Xavier Francis, guests Brian Smith and Joe Hill discuss ISO 9001 Clause 7.1.5 on calibration within a Quality Management System (QMS). They elaborate on the importance of calibration in ensuring the accuracy of tools and equipment used in monitoring and measuring product quality. They discuss the specifics of the clause, including requirements for monitoring resources, measurement traceability, and the responsibilities organizations have towards calibration. They also cover how organizations should handle equipment that is out of calibration, and the proper management and retention of calibration records. The episode aims to clarify the clause's provisions and offer practical advice on maintaining compliance and ensuring measurement reliability within a QMS. Helpful Resources:   ISO 9001 Clause 7.1.5:  https://www.thecoresolution.com/clause-7-1-5-iso-9001-explained   ISO 9001 Clause 7:  https://www.thecoresolution.com/iso-9001-clause-7   For All Things ISO 9001:2015: https://www.thecoresolution.com/iso-9001-2015   Contact us at 866.354.0300 or email us at info@thecoresolution.com   A Plethora of Articles: https://www.thecoresolution.com/free-learning-resources   ISO 9001 Consulting: https://www.thecoresolution.com/iso-consulting  

In this episode, Adam Isaac Rae will share with us is TOP 5 common NCs during an ISO 13485 audit. He will go through all the clauses and for each of them he will bring his TOP issue. So after that the exercise will be for you to check if this issue can be identified within your QMS. So good research to you.  Who is Adam Isaacs Rae?  Chartered quality professional with a Master's Degree focused in Strategic Quality Management from University of Portsmouth. Demonstrated history of working aerospace & defence, medical device and the construction industry. Skilled in Operations Management, Lean Six Sigma, Failure Mode and Effects Analysis (FMEA), Value Stream Mapping and Supply Chain Management. Who is Monir El Azzouzi?  Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.  Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.  Link Adam Isaacs Rae LinkedIn:  https://www.linkedin.com/in/adam-isaacs-rae/ Social Media to follow Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice

In this episode of the Quality Hub, Xavier Francis, and Norm Verbeck discuss the critical importance of workforce engagement in driving business success and improving your QMS. They discuss the benefits of engaged employees such as lower burnout, staying longer, overall performance, and more. They also discuss key strategies to gain better workforce engagement, including robust onboarding, ongoing training, effective leadership, and more. Aligning individual and departmental roles with organizational goals ensures employees understand their contributions, while face-to-face in-person or virtual interactions build trust and cohesion. The discussion highlights that workforce engagement is beneficial and essential for organizational success.   Helpful Resources:   QMS:  https://www.thecoresolution.com/quality-management-system-maturity   For All Things ISO 9001:2015: https://www.thecoresolution.com/iso-9001-2015   Contact us at 866.354.0300 or email us at info@thecoresolution.com   A Plethora of Articles: https://www.thecoresolution.com/free-learning-resources   ISO 9001 Consulting: https://www.thecoresolution.com/iso-consulting

Send us a textIn this episode of the QMS Podcast, our host Claire Taylor is joined by a fantastic line-up of guests. First, QMS Chair, Kate Rowell provides a New Year's update and greetings to the audience, while Iain Macdonald, QMS Market Intelligence Manager, offers valuable insights into market trends and what to expect in the year ahead.The highlight of this episode is our special guest, Dr. Carrie Ruxton, a renowned dietitian with over 20 years of experience. Carrie dives deep into the myths surrounding red meat, providing expert clarity on its role in a balanced diet. With a rich background consulting for food companies, serving on the Meat Advisory Panel, and contributing to Food Standards Scotland, Carrie's knowledge and rural Scottish roots offer a unique perspective on nutrition and farming.Tune in for a mix of industry trends, health insights, and a closer look at the 2025 Toolkit to support the positive narrative around Scotland's red meat.To access the toolkit visit the QMS website!Here is a link to all episodes of QMS's podcast https://qmscotland.co.uk/news-media/qms-podcast

In this episode of the Quality Hub podcast, Xavier Francis and Suzanne Strasser discuss year-end strategies for optimizing ISO Quality Management Systems (QMS). They emphasize evaluating resources, leveraging technology, and analyzing trends to address gaps and improve efficiency. Key points include engaging stakeholders, adapting to external changes, and more. The episode highlights the importance of employee empowerment, process optimization, and embracing tools like AI and data analytics to prepare for future challenges. Helpful Resources: What is a mature QMS? https://www.thecoresolution.com/quality-management-system-maturity   ISO 9001 Gap Analysis: https://www.thecoresolution.com/iso-9001-gap-analysis-explained   For All Things ISO 9001:2015: https://www.thecoresolution.com/iso-9001-2015   Contact us at 866.354.0300 or email us at info@thecoresolution.com   ISO 9001 Standards: https://www.thecoresolution.com/iso-90012015-standard-1   A Plethora of Articles: https://www.thecoresolution.com/free-learning-resources   ISO 9001 Consulting: https://www.thecoresolution.com/iso-consulting    

Klinisch Relevant ist Dein Wissenspartner für das Gesundheitswesen. Drei mal pro Woche, nämlich dienstags, donnerstags und samstags, versorgen wir Dich mit unserem Podcast und liefern Dir Fachwissen für Deine klinische Praxis. Weitere Infos findest Du unter https://klinisch-relevant.de

Send us a textIn this episode, we explore two exciting topics; Rugby and A World Without Cows. First, to kick off the episode, we have Sarah Millar Chief Executive of QMS reflecting on the year and the exciting work QMS has taken on.We are then joined by Aileen Marchant discussing the unique QMS rugby partnership, the upcoming development days, and why rugby is helping to highlight the role of sustainable red meat.We also dive into A World Without Cows, a documentary exploring the global agricultural debate. Filmmakers Brandon Whitworth and Michelle Michael share stories from their travels, highlighting the crucial role of livestock in combating climate change.Join us for a thought-provoking conversation on leadership, partnerships, and the future of sustainable agriculture.Here is a link to all episodes of QMS's podcast https://qmscotland.co.uk/news-media/qms-podcast

In this podcast episode of the Quality Hub,  Xavier Francis and Suzanne Weber-Smatko discuss the significance of understanding The Context of the Organization and its Quality Management System (QMS). They explore internal issues such as organizational structure, and employee competency, alongside external factors like competitive markets, regulatory changes, and more. Stakeholders are identified, with a focus on meeting their expectations for quality, compliance, and engagement. Organizations are encouraged to monitor market trends, regulatory updates, and more while fostering a culture of continuous improvement, as well as others. The episode emphasizes the value of documenting feedback, supporting employees, and aligning QMS initiatives with strategic goals as well as other topics. Helpful Resources:   https://www.thecoresolution.com/iso-9001-clause-4   https://www.thecoresolution.com/iso-9001-clause-4-1-explained   For All Things ISO 9001:2015: https://www.thecoresolution.com/iso-9001-2015   Contact us at 866.354.0300 or email us at info@thecoresolution.com   ISO 9001 Standards: https://www.thecoresolution.com/iso-90012015-standard-1   A Plethora of Articles: https://www.thecoresolution.com/free-learning-resources   ISO 9001 Consulting: https://www.thecoresolution.com/iso-consulting  

In this engaging episode of the Global Medical Device Podcast, Etienne Nichols and Devon Campbell dive into the complexities of verification and validation (V&V) in medical device development. Whether you're a medtech startup founder or an industry veteran, this conversation offers essential insights on creating robust V&V processes. Devon shares practical advice on defining user needs, writing strong design inputs, conducting pre-verification testing, and ensuring that verification protocols provide meaningful evidence. The discussion explores how to avoid common pitfalls, optimize your design reviews, and strategically approach V&V for complex devices, offering listeners a wealth of actionable takeaways for navigating regulatory challenges and accelerating market access.Key Timestamps:00:01 – Introduction to Greenlight Guru's QMS capabilities03:15 – Setting the stage: Why verification and validation matter08:30 – Differences between verification and validation explained12:50 – Importance of strong user needs and design inputs23:45 – Writing effective user needs and identifying users33:00 – Creating robust design inputs and their sources beyond user needs40:10 – From design inputs to design outputs: Key considerations48:20 – Best practices for conducting design reviews and managing revisions57:15 – Verification strategies: The importance of pre-verification01:05:40 – Common challenges in V&V, including sample sizes and justifying tests01:15:10 – Using feedback during testing and leveraging observations01:23:00 – Final takeaways and practical advice for V&V successStandout Quotes:"Verification asks if we built the product correctly, while validation asks if we built the right product for the user." – Devon Campbell"You can't do verification or validation without strong, well-informed requirements. Weak requirements lead to validation failures." – Devon Campbell3 Key Takeaways:Verification and Validation Are Not the Same: Understand that verification ensures your device meets specified design inputs, while validation confirms it meets user needs and functions as intended.Pre-Verification Testing Minimizes Risk: Conducting a "pre-verification" run allows you to refine testing protocols and identify potential design issues before formal verification begins.Define Users Clearly in User Needs: Avoid generic statements; specify which user (e.g., clinician, technician, patient) has which needs to ensure robust validation testing.References:Devon Campbell's Consulting – Connect with Devon for more insights on product development.Etienne Nichols' LinkedInGreenlight Guru's QMS SoftwareMedTech 101:Verification vs. Validation – Verification checks if a product meets specified requirements, while validation ensures it fulfills the needs and expectations of its intended users. Both are critical steps in medical device development, and their successful execution depends on precise, testable requirements.Audience Engagement:Poll Question: "What's been your biggest challenge in navigating verification and validation for...

In this episode, Monir El Azzouzi will help you build the perfect Quality Management System. He will give you his recipe to start the creation of a QMS and show you step by step what you should do.  Who is Monir El Azzouzi?  Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.  Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.  Link Blog: Does your Quality Manual look like that? https://easymedicaldevice.com/quality-manual/  Video: How to get ISO 13485 certified? https://www.youtube.com/watch?v=paT2oR0uwjg  ISO 13485 standard: https://knowledge.bsigroup.com/products/medical-devices-quality-management-systems-requirements-for-regulatory-purposes?version=tracked  Blog: ISO 13485 Mandatory procedures: https://easymedicaldevice.com/iso-13485-procedure/  Social Media to follow Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice

What makes many of Australia's most iconic brands stand out is their exceptional branding.The creative process of branding demands relentless effort, strategic vision, and brilliant minds.Hans Hulsbosch is a name synonymous with branding in this country. A renowned designer and branding expert, Hans has been at the helm of projects for some of Australia's biggest names—Qantas, Woolworths, and Virgin Australia—turning their brand strategies into benchmarks for the industry. As the founder of Hulsbosch Design, he's been instrumental in shaping the way Australians experience these household names.His son, Jaid Hulsbosch, with over 20 years of global experience, joined the family agency after working in businesses around Europe. Now as Director, Jaid oversees strategy, business development, and culture, driving Hulsbosch's continued success and creative edge.Together, this father-son duo has propelled Hulsbosch into Australia's gold standard of branding. Their portfolio includes standout work for organisations like Tennis Australia, Liquorland, Football Australia, Rebel, SBS World, Channel 7, Taronga Zoo, and QMS—just to name a few. Tune in as Hans shares how he crafted the messages of these iconic brands, dives into the creative process behind them, explores the unique father-son dynamic at Hulsbosch Designs, Jaid reveals what the best brands get right, and much more.You can subscribe to the Mentored newsletter here: https://mentored.com.au/newsletter-sign-upJoin the Facebook Group.Follow Mark Bouris on Instagram, LinkedIn & YouTube. Hosted on Acast. See acast.com/privacy for more information.

In this episode, Rod Beuzeval will explain the reason why FMEA is maybe not the right method for your Risk Management per ISO 14971. So, check this and tell us if you agree.  Who is Rod Beuzeval?  Rod has 25+ years of experience in the medical device and pharmaceutical industry. He has expertise in regulatory strategy, technical documentation, QMS systems, standards compliance, clinical evaluation, risk management, project management, and remediation activities. Rod has worked for a notified body, conducted audits against EN ISO 13485, and supported reviews of technical documentation for medical device manufacturers in Europe. His experience includes Class I, II, and III devices, software as a medical device, drug delivery devices, IVDs, and active implantable medical devices.  Who is Monir El Azzouzi?  Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.  Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.  Link Leap Compliance LinkedIn: www.linkedin.com/company/leap-compliance  Leap Compliance website: www.leapcompliance.com  ISO 14971 Standard: https://www.evs.ee/en/evs-en-iso-14971-2019  Video: What is ISO 14971: https://www.youtube.com/watch?v=5C2CzApjI_U  Podcast: Why Risk Management is important for Medical Devices: https://podcast.easymedicaldevice.com/207-2/  eQMS for Risk Management: https://eqms-smarteye.com/  Social Media to follow Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice

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In this episode of the Global Medical Device Podcast, host Etienne Nichols is joined by quality and regulatory expert Ashkon Rasooli to explore the essentials of creating a high-impact, non-burdensome Quality Management System (QMS). Ashkon shares his four guiding principles for building an effective QMS—emphasizing quality over proceduralism, culture over mandate, redundancy over duplication, and conciseness over verbosity. This conversation dives into strategies for optimizing QMS implementation, reducing overhead, and integrating quality culture company-wide. The episode wraps with tactical advice for new medical device founders on setting up their QMS for long-term success.Key Timestamps:00:02 – Intro to Greenlight Guru and Episode Topic03:30 – Introducing Ashkon Rasooli and his background05:15 – Defining the “Non-BS QMS” approach06:45 – Principle #1: Quality Over Proceduralism12:00 – Navigating deviations in QMS and avoiding extremes14:45 – Principle #2: Culture Over Mandate22:10 – Principle #3: Redundancy Over Duplication29:30 – Principle #4: Conciseness Over Verbosity37:00 – The Importance of Designing for Regulatory and Quality from the Start46:30 – Tactical QMS advice for new medtech founders57:00 – Wrapping Up and Key TakeawaysStandout Quotes:"There is a cost to quality. But quality done right can also be an enormous value-add, not just a regulatory checkbox." – Ashkon Rasooli"A QMS should serve quality and compliance, but it has to be intuitive for every person in your company. Complexity does not mean quality." – Ashkon Rasooli3 Key Takeaways:Quality Over Proceduralism: Focus on the intent and impact of QMS processes rather than rigid adherence to procedures that may not reflect the realities of your business.Culture Over Mandate: Building a culture of quality involves engaging every employee, not just those in quality roles, to ensure shared responsibility and proactive efforts.Design for Quality Early On: Engaging with quality and regulatory advisors at the architecture and design phase can prevent costly rework and optimize compliance pathways.References:Ashkon Rasooli on LinkedInEtienne Nichols' LinkedInGreenlight Guru's QMS Software: www.greenlight.guruMedTech 101:QMS (Quality Management System) – A structured system of procedures and processes covering all aspects of design, development, manufacturing, and distribution to ensure product safety, effectiveness, and regulatory compliance. Essential for medtech companies seeking to market devices in most global markets.Audience Engagement:Poll Question: "Does your company treat quality as a compliance necessity or a business differentiator? Share your thoughts!"Feedback:Love this episode? Have ideas or topics you want us to cover? Email us at podcast@greenlight.guru and leave a review to help others discover the Global Medical Device Podcast.

Happy Trails” is an album recorded from performances at the Fillmore East & West venues. Most of the tracks are reworkings of some of Bo Diddley's tracks. Quicksilver Messenger Service was very influential but wasn't commercially successful The 500 invited Wayne Federman & DJ Morty Coyle back to unpack “Happy Trails”, the last QMS album to feature their original lineup.  Follow Wayne on Instagram: https://www.instagram.com/instafederman/ Follow Wayne on Twitter: https://x.com/federman Follow Morty on Instagram: https://www.instagram.com/djmortycoyle https://www.instagram.com/alldaysucker/ Follow Josh on Instagram: https://www.instagram.com/joshadammeyers/ Follow Josh on Twitter: https://twitter.com/JoshAdamMeyers Follow Josh on Facebook: https://www.facebook.com/joshameyers Follow The 500 on Instagram: https://www.instagram.com/the500podcast/ Follow The 500 on Twitter: https://twitter.com/the500podcast Follow The 500 on Facebook: https://www.facebook.com/The500PodcastWithJAM/ Email the show: 500podcast@gmail.com Check the show's website: http://the500podcast.com DistroKid Artist Of The Week: Giant Sand https://youtu.be/tQBa7c2e5Zk?si=ENrMInRN9RMn_4xa Learn more about your ad choices. Visit megaphone.fm/adchoices

In this episode of the Quality Hub podcast, Xavier Francis discusses ISO 9001 Clause 6.3 on Change Management with Brian Smith and Brian Smatko both from Core Business Solutions. The conversation emphasizes the importance of planning and managing changes within a Quality Management System (QMS) to avoid unintended consequences and maintain consistency. They highlight that major changes, such as new equipment or process modifications, should be addressed in management reviews, considering multiple factors like and potential impacts on other processes. Proper documentation, communication, and addressing resistance to change are crucial to ensure smooth transitions and maintain the integrity of the QMS. Helpful Resources: https://www.thecoresolution.com/iso-9001-clause-6-3-explained For All Things ISO 9001:2015: https://www.thecoresolution.com/iso-9001-2015 Contact us at 866.354.0300 or email us at info@thecoresolution.com ISO 9001 Standards: https://www.thecoresolution.com/iso-90012015-standard-1 A Plethora of Articles: https://www.thecoresolution.com/free-learning-resources ISO 9001 Consulting: https://www.thecoresolution.com/iso-consulting  

In this episode of the Global Medical Device Podcast, host Etienne Nichols speaks with Dr. Asha Parekh, CEO and co-founder of Frontline Medical Technologies, about her path from a biomedical engineer to an "accidental entrepreneur." Dr. Parekh shares how her desire to create impactful medical devices led to the development of the COBRA-OS, a life-saving tool used in trauma care, including military and postpartum hemorrhage situations. The conversation touches on the challenges and victories of securing funding, navigating regulatory hurdles, and maintaining a mission-driven company focused on patient impact. For those interested in MedTech, this episode provides inspiration, practical insights, and a behind-the-scenes look at innovation in healthcare.Key Timestamps:[03:22] – Asha Parekh shares her transition from biomedical engineer to accidental entrepreneur.[12:35] – Developing the COBRA-OS and the moment Asha realized the life-saving potential of her product.[22:10] – The role of passion in overcoming challenges as a MedTech entrepreneur.[35:42] – The importance of securing funding and the challenges of working with quality and regulatory partners.[52:20] – How to craft a compelling pitch to secure funding for your MedTech device.[01:04:30] – Asha's milestone moments, including the COBRA-OS being used at Formula One race tracks.Quotes:"Passion is what drives you through the tough days. It's what makes the challenges bearable because the impact you're making is worth it." – Asha Parekh"Pitching is an art form. Telling a compelling story about your product, especially one that saves lives, can make all the difference." – Asha Parekh"You are the expert on your device. Never forget that, even when you're leaning on regulatory experts. Trust your own knowledge of your product." – Asha Parekh"The moment I realized that COBRA-OS could save lives, I knew we had to pursue it full-time." – Asha ParekhKey Takeaways:Top 3 MedTech Trends:Growing Impact of Trauma Care Devices – Devices like the COBRA-OS are becoming critical in high-risk environments such as military and emergency settings.Regulatory Complexity – Expanding into international markets (e.g., achieving CE mark) requires navigating a web of regulatory requirements.Funding & Innovation – Securing funding is pivotal for early-stage MedTech companies, especially when aiming for large-scale regulatory testing.Top 3 Practical Tips for MedTech Entrepreneurs:Find a Mission You're Passionate About – It will sustain you through difficult phases.Master the Art of Pitching – A compelling story can unlock funding opportunities.Be Proactive in Regulatory Knowledge – Don't rely solely on consultants; know your product's regulatory pathway inside and out.References:Frontline Medical Technologies – Learn more about COBRA-OS and its use in trauma care at Frontline MedTech.Greenlight Guru – For quality and regulatory management solutions, visit Greenlight Guru.Rook Quality Systems – Learn more about QMS consulting at Rook Quality Systems.Connect with Etienne Nichols on LinkedIn...

This episode is a cross-post of an interview I did with Etienne Nichols over at the Global Medical Device Podcast at GreenLight Guru(Episode #380). In this episode, Etienne and I discuss: 02:50 The Start of the Combinate Podcast 06:00 Efficiency and Tools in Podcast Production 08:40 Understanding Combination Products 09:43 Regulatory Frameworks and Definitions 13:46 Challenges and Misconceptions in the Industry 20:47 Evolution of Regulations: QMSR and Part 4 22:05 Exploring Unique Podcast Episodes 25:56 The Pyramid of Regulations 30:40 The Role of Coaching and Mentorship 32:59 Trends in Combination Products 35:23 Recommended Books and Final Thoughts 37:04 Encouragement for Lifelong Learning Subhi Saadeh is a Quality Professional and host of the Combinate Podcast. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee. Etienne Nichols is a Medical Device Guru and Mechanical Engineer who loves learning and teaching how systems work together. He has both manufacturing and product development experience, even aiding in the development of combination drug-delivery devices, from startup to Fortune 500 companies and holds a Project Management Professional (PMP) certification. Having managed cross-functional teams to update designs of legacy products, Etienne understands the pain of following the Design Controls process in paper-based QMS environment. His expansive knowledge, experience, and passion with medical devices is evenly matched with how much he enjoys helping customers work efficiently through the design and development process to bring safe, high quality products to market

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we're focusing in on a regulatory piece that's been mentioned numerous times with regard to other topics we've discussed. This episode is focused on CAPA or corrective and preventive action. We're digging into the CAPA, what it is, its purpose, and how to best implement it. Specifically, the following questions are addressed:Could you please briefly highlight the reasons FDA issues 483 observations and warning letters?What is a CAPA and when should it be used?What are the most common reasons for 483s and warning letters involving a CAPA?How do you know if your CAPA is doing what it's supposed to do?Is industry taking the wrong approach with a CAPA? Is there a better way we could be looking at this issue?How are CAPAs related to other aspects of the QMS, such as risk, post-market surveillance, or complaint handling?Do you have examples that might help illustrate what we've discussed?What else is important and/or what are the most important takeaways?Listen to this discussion and see if you have a better understanding of CAPAs. If you'd like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at sfenske@rodmanmedia.com and we'll see if we want to address your ideas/inquiries/suggestions in a future episode.Send us a textFor more medtech news and information, visit www.mpomag.com.

Explore the essential role of quality management in small medical device companies with Vernon Baker, a seasoned engineer. Learn about core QMS activities, regulatory intelligence, effective communication with top management, and key skills for aspiring quality managers. Gain valuable insights on supplier management, risk assessment, and regulatory compliance for startups and growing medical device firms.

In this episode, host Etienne Nichols is joined by Mark DuVal, President and CEO of DuVal & Associates, and Kathy Herzog, Senior Regulatory, Quality, and Compliance Associate at DuVal & Associates. They delve into the recent FDA proposed rule for wound dressings, addressing the classification and regulatory impacts on medical device manufacturers. The discussion covers the historical context, the potential implications for the industry, and strategies for companies to navigate these changes.Key Timestamps:[00:00] - Introduction to the episode and guests[02:15] - Overview of Greenlight Guru's QMS software[04:30] - Introduction to the FDA's proposed rule on wound dressings[06:00] - Mark DuVal discusses the broad implications of the proposed rule[12:45] - Kathy Herzog explains the performance requirements and administrative record[22:00] - Discussion on industry response and potential litigation[30:30] - Impacts on existing and new products in the market[40:20] - Strategies for companies to navigate the proposed changes[50:00] - Broader implications for the FDA and potential future regulations[60:00] - Final thoughts and ways to stay informedQuotes:"This proposed rule feels like a solution in search of a problem." - Mark DuVal"It's unsustainable that small wound dressing manufacturers would have to bear that burden on the back of an individual wound dressing." - Kathy Herzog"FDA's move to over-regulate well-settled product categories is deeply concerning." - Mark DuValKey Takeaways:MedTech Trends:The FDA's proposed rule could significantly impact the classification and regulation of wound dressings.There is substantial industry opposition to the proposed rule, with many companies and trade associations voicing their concerns.The broader implications of the FDA's actions suggest a shift towards more aggressive regulatory measures.Practical Tips:Stay informed about regulatory changes and participate in comment periods to voice concerns.Prepare for potential new testing and data requirements by reviewing current performance testing protocols.Engage with industry groups and legal experts to understand the full impact of proposed regulations.Future Developments:How will the FDA address industry pushback and potential litigation against the proposed rule?Will there be additional guidance from the FDA to help manufacturers navigate the new requirements?What other product categories might the FDA target for reclassification in the near future?References:Greenlight Guru QMS SoftwareFDA Proposed Ruling on Wound DressingsDuVal & Associates Client Alert on FDA Proposed RuleAlliance of Wound Care StakeholdersWashington Legal FoundationConnect with Etienne...

In this episode of the Global Medical Device Podcast, Etienne Nichols sits down with Dr. Gail Lebovic, an internationally recognized oncoplastic surgeon and innovative entrepreneur. They delve into the evolving landscape of MedTech, focusing on the shift from traditional reimbursement models to direct-to-consumer strategies. Dr. Lebovic shares her journey of pioneering nasal health products during the COVID-19 pandemic, emphasizing the importance of flexibility and addressing real clinical needs. The conversation explores the broader implications for the future of healthcare, prevention, and patient empowerment.Key Timestamps:[02:15] – Introduction to Dr. Gail Lebovic and her background.[06:45] – Discussing the shift from traditional payer models to direct-to-consumer strategies.[12:30] – Challenges faced during the COVID-19 pandemic and pivoting strategies.[20:00] – The importance of flexibility in MedTech innovation.[30:10] – The significance of nasal health and hygiene.[40:25] – Going to market on Amazon and its impact on the business.[50:50] – Future trends in MedTech and women's healthcare.[01:05:15] – Advice for aspiring MedTech entrepreneurs.Quotes:"People are smart, our patients are smart, and all of our patients are consumers." – Dr. Gail Lebovic"Healthcare is really not healthcare; it's really sick care." – Dr. Gail LebovicTakeaways:Key Insights:The shift from traditional reimbursement models to direct-to-consumer strategies can enhance patient care and accessibility.Prevention and self-care are becoming increasingly important in the healthcare landscape.Innovation in MedTech requires flexibility, robust research, and addressing real clinical needs.Practical Tips:Stay open to changing strategies based on market demands and environmental factors.Ensure your product stands out by maintaining high clinical standards, even in consumer markets.Utilize platforms like Amazon to reach a broader audience while maintaining rigorous quality controls.Future Questions:What new preventive health products will emerge in the next five years?How will the healthcare system adapt to increasing patient empowerment and self-care trends?References:Greenlight Guru – For all-in-one QMS software designed specifically for the medical device industry. Visit Greenlight Guru.Silicon Valley Innovations – Founded by Dr. Gail Lebovic, introducing anatomically directed drug delivery. Learn More.Dr. Gail Lebovic on LinkedIn – Connect with Dr. Lebovic for more insights into MedTech innovations. Connect on LinkedIn.Nasoclenz on Amazon - Check out how Silicon Valley Innovations is marketing their products direct-to-consumer on Amazon. Learn more.MedTech 101:Direct-to-Consumer (DTC) Strategy:A direct-to-consumer (DTC) strategy involves marketing and selling products directly to consumers, bypassing traditional healthcare providers or payers. This approach can increase accessibility, reduce costs, and empower patients to take control of their...

Kevin + Mykie's prepare to board with their growing Pirate Build-a-Crews! This week, we're cornering ourselves a  QUARTERMASTER to maintain man and mast! We've got fantastically funny First Mates, Historical heroes of second rank and quality QMs from not so sea-worthy stories. Join us as we turn things over to the next best person for the job and Get to listening ye scurvy dogs!Kevin and Mykie will be at BA-CON 2024!happening July 6-7, 2024 in the Houston Marriott South at Hobby AirportFor info and tickets check out https://www.ba-con.live/Support the podcast and buy us a cup of joe!Visit www.buymeacoffee.com/assumingpod for the perks and thanks for being awesome Positrons.