Let's talk global medical device + IVD regulatory services

In this webinar, we navigate you through the design control requirements of the main regulators. Discuss the design and development process for medical devices, including software. Share our experience and provide practical tips for implementation into your quality management system to produce reliable documentation which demonstrates regulatory and quality compliance.

Regulatory bodies have emphasised the importance of Risk Management under ISO 14971 in the development of medical devices and in-vitro diagnostics. In this webinar, led by Senior Consultant, Yervant Chijian we explore how Risk Management is critical to regulatory frameworks and provide an overview of the fundamental principles and key standards.In addition, best practices for implementing risk management activities within your organisation including post-market considerations will be discussed and outlined.Presenter: Yervant Chijian, Brandwood CKC

As the global medical practice undergoes drastic change embracing faster access to innovative technologies, getting the regulatory strategy right from the onset can mean the difference between success and failure. In this webinar, we discuss the key considerations for registering innovative products and changes to existing products incorporating innovative modifications. We will focus on the current regulatory issues and requirements when evaluating alternative pathways for TGA, EU, and the US including rare-disease designations, priority review, and provisional approvals. Special note will be taken on how the MDR and IVDR transitions are impacting innovative product registrations and product changes. Key trends such as the use of Real World Evidence, MDSAP, and risk-based biocompatibility management will be discussed.Presenter: Luis Jimenez, Brandwood CKC

Medical device and IVD manufacturers who wish to distribute their products in Australia and New Zealand need to appoint a local sponsor. In this webinar, Brandwood CKC Consultant, Orsola Regaglia, covers the key requirements of Sponsors for TGA and MedSafe, their role in the premarket and postmarket phases. We provide key recommendations for manufacturers and sponsors on how to select the right partner and effectively interacting between the main entities and the Regulators.Presenter: Orsola Regaglia, Brandwood CKC

2020 was a year like no other and COVID-19 has certainly challenged the Pharmaceutical, Medical Device and Diagnostic Industries. Even with all that was going on with COVID-19 and making COVID-19-related medical products available, 2020 was a banner year for guidances issued by the US Food and Drug Administration (FDA). In this month’s webinar, our Directors, Rob Stringer and Terrance Thiel will discuss those guidances that have the most impact on the pharma, medical device and diagnostic products, by providing an overview, understanding and examples of these guidances’ effects, including the potential effects to other regulatory jurisdictions. Please join us for this February webinar and feel free to ask any FDA guidance questions in advance.Presenters: Robert Stringer and TJ Thiel, Brandwood CKC

This webcast recording reviews the most salient global regulatory changes in 2020 for Medical Devices and Diagnostics and how they impact the Asia Pacific. Brandwood CKC’s TJ Thiel and John Lockwood of Pearl Pathways, delve into the major regulatory bodies’ most important regulatory changes and analyse the potential impacts on the Asia Pacific. There is also a focus on changes in Australia’s TGA, Japan’s PMDA, and China’s NMPA. Additionally, this presentation takes into account the impact the COVID-19 pandemic has had and how regulators have adapted regulatory changes to meet medical supply demand. The presentation and Q&A were pre-recorded during a RAPS (Regulatory Affairs Professional Society) US Chapter program.

2020 has been a year like no other and COVID-19 has certainly challenged the Medical Devices Industry. In this month’s webinar Grant Bennett and T.J. Thiel will discuss the most frequently asked regulatory questions for medical devices and diagnostics in this 2020 year-end review.Several key topics will be covered, including disinfectants, leaflets/implant cards and adverse event reporting. Although the most frequently asked questions will be covered, there is an opportunity to have any of your specific questions answered – just be sure to submit them when registering.Presenters: Grant Bennett and TJ Thiel, Brandwood CKC

In recent times, the TGA has introduced a range of new prescription medicine application pathways that utilise overseas evaluations and accelerate market access. The team at Brandwood CKC have extensive experience with these new pathways and this webinar will outline the latest developments and provide insights as to the pros and cons of each pathway. A must for companies looking to accelerate Australian regulatory approvals and maximise efficiencies in the global roll out of new products.Presenter: Robert Stringer, Director and Principal Consultant

COVID-19 has challenged the health systems’ dynamics in many ways and industry and regulators have responded by implementing special actions to ensure patients and caregivers are provided with adequate diagnostics, therapies, and protective equipment. In this webinar, Orsola Regaglia and Jean Boudaud will present an overview of the response to COVID-19 from the regulators in key geographies. We will discuss pathways for COVID-related devices regulatory approvals and share our experience with the regulatory review processes.Presenters: Orsola Regaglia, Consultant and Jean Boudaud, Senior Consultant and Team Lead

This podcast will provide an update to our 2019 webinar on In Vitro Diagnostic products, as well as current situations in US, Australia and other key geographies. Hear from TJ Thiel on recent regulatory changes and how businesses can best prepare for upcoming regulatory submissions for IVDs.Presenter: TJ Thiel, Consulting Operations Manager and Principal Consultant, Brandwood CKC

This webinar will provide an update to our 2019 webinar on Software as a Medical Device (SaMD) and Software in Medical Devices. Yervant Chijian will highlight recent regulatory changes as they apply to Medical Device software and how businesses can best prepare for upcoming regulatory submissions.Presenter: Yervant Chijian, Senior Consultant

As regulators around the world look more closely at the Clinical Evaluation Report in support of a device’s safety and efficacy, we revisit the key aspects of discussion on which manufacturers and sponsors should focus their efforts.Listen in to hear Heyam Kalla provide guidance in navigating the world of CERs that meet regulatory expectations, including those that may not be expressly written into the guidance.Presenter: Heyam Kalla, Senior Consultant, Brandwood CKC

The Australian Therapeutic Goods Administration recently implemented several new initiatives that enable sponsors to utilise regulatory approvals from other jurisdictions (e.g. USA, Canada, Europe) to accelerate prescription medicine approval in Australia. This webinar outlines how these processes work, what criteria are applied, and the corresponding impact on regulatory timelines – a must-listen for those seeking Australian approvals for Prescription Medicines, Biological Medicines, Generics and Biosimilars in this presentation.Presenter: Robert Stringer, Director and Principal Consultant, Brandwood CKC

With disrupted supply chains, shortages of medicines, masks, ventilators and test kits, everyone wants the regulator’s attention – right now, today. The good news is that pandemic planning has been a thing for regulators for many years. And they have the powers and the laws to do things differently. From expedited reviews to waivers of change applications to emergency supply approvals without product registrations, it all becomes possible. Regulators still expect to see some sort of evidence of safety and efficacy though it may be much more flexibly interpreted.Do you want to get a medical device or medicine approved quickly in response to COVID-19? Hear from Arthur Brandwood and Robert Stringer as they discuss how Australia’s TGA has become fleet of foot in these troubled times.

As the ISO Technical Committee 194 prepares to meet later this year, we look at the planned changes to the standards, the rising prominence of chemical characterisation and the efforts to eliminate animal testing.Join James Morrison and Jean Boudaud to learn what’s hot in ISO 10993 biocompatibility evaluation.

With just a few months to go to the MDR transition deadline, manufacturers will be subject to a raft of new formal postmarket reporting requirements. And they all rely on active data collection. Inadequate monitoring leaves a manufacturer defenceless in the event of a product failure.Join Belinda Dowsett and Heyam Kalla to learn how good postmarket and QA processes are the keys to disaster prevention.

Learn how Australia does faster drug approvals through shared evaluations and leveraging international approvals. How to minimise risks from the European MDR devices train wreck and the growing trend for “Reliance” as CE mark becomes harder and rarer. And why global drug shortages mean you should be careful what you eat in the holiday season. Join Arthur Brandwood and Nancy Stringer to learn what to watch out for and how to manage your risks in 2020.

For our last webinar of the year, we are honoured to have a special guest: Francisco Vicenty, Program Manager, Case for Quality US FDA/CDRH/Office of Compliance join us.The Case for Quality is a program developed under the auspices of the Medical Device Innovation Consortium (MDIC) where various stakeholders, including US FDA and the Medtech industry, have partnered to identify practices that lead to higher device quality. The program has been underway for several years and includes the CDRH Case for Quality Voluntary Improvement Program (CFQ VIP), 18 companies and 51 facilities that undergo periodic assessment focused on practices that advance quality and safety and lead to better outcomes for patients.Hear from FDA’s leadership about the Case for Quality program. We will discuss current program activities as well as what the future holds for CfQ. Get an agency perspective, including the benefits to companies participating in the program.Presenters: Arthur Brandwood, Brandwood CKC and Francisco Vicenty, US FDA

Although Medical Devices are of more immediate focus with the implementation of the MDR, it is possible that the changes for IVD devices in Europe may be even more significant and burdensome. Having a plan early over the next two years will be critical for your diagnostic business.Please join us for this webinar, hosted by TJ Thiel, Principal Consultant for Brandwood CKC, and Sue Spencer, Head of In Vitro Diagnostics & Principal Consultant for Qserve, as they discuss the changes from the IVDD to IVDR and how you can position your business to address this dramatic change.

Rapidly changing technologies and access to software through connected platforms have blurred the lines between consumer and medical products.This has historically resulted in some challenges for healthcare regulators and Industry to recognize software as medical devices (SaMDs) and applicable regulatory requirements.In this month’s webinar, our Senior Consultants, Yervant Chijian and Jean Boudaud will provide some insights on how to navigate through this evolving topic.

For years regulators have talked about the importance of continuing monitoring and follow up of approved devices – so called Postmarket Regulation, or Vigilance in Euro-speak.But frankly, industry focus and regulator resources have always been weighted towards up-front review – premarket evaluation.That’s all changing. The European MDR includes explicit and comprehensive requirements for postmarket follow up and reporting – and a shiny new database to contain all that information. Australia’s TGA is consulting on a range of new postmarket initiatives and the US FDA recently moved to abandon summary reporting of adverse events, mandating public, case by case reporting of incidents associated with devices such as breast implants.Join Arthur Brandwood and TJ Thiel to hear why it’s time to get real on Postmarket. And how to manage your devices through the whole lifecycle.

Good documentation is about doing it once. We explore how to use the Design Controls to build a core Technical File, and to use it to create DHF, DMR, Design Dossier and regulatory filings such as 510(k) and PMA. We will also explore the impact of the MDR to your Technical File.Presenters: Terrance Thiel and Grant Bennett, Brandwood Biomedical.

This month we look at global regulatory strategy in times of uncertainty. Remember just yesterday when CE was a smooth and quick process and CE mark gave a passport to so many other markets. Suddenly everything changed. We look at what the implications of changes in Europe (MDR Brexit), the US (New 5410k pathways, SaMD) and other markets such as Australia (leveraging Canada, Japan as well as US and CE) and of course, MDSAP. And amongst all of this we have to keep in sight the commercial and marketing objectives. Join Arthur Brandwood and Grant Bennett who ask: “how do I build a global regulatory strategy that is fit for today, and for whatever tomorrow may bring?”

As Europe transitions to the MDR and TGA focuses more on clinical evidence in applications, creating a Clinical Evaluation Report (CER) that meets all regulators’ expectations seems like an impossibility. Understanding MEDDEV 2.7/1 revision 4 is difficult enough, without having to consider individual requirements of the individual regulators. Hope is not lost, a single report that will meet the various regulatory body’s scrutiny can be created.Join T.J. Thiel and Heyam Kalla as they provide guidance in navigating the world of Clinical Evaluation Report and the MEDDEV 2.7/1 revision 4 guidance. Heyam and T.J. will discuss the items on which manufacturers and sponsors should focus, based on recent feedback from European Notified Bodies and TGA review. This webinar will help the audience understand how to create a CER that is complete and meets all regulatory expectations, particularly those that are not expressly written into the guidance.

A frank conversation between internationally recognised experts on four big ticket items in medical device evaluation, including:- Changing Standards and changing regulator expectations.- Physical & Chemical information.- What to do about the whole “Risk Management Process” idea.- Skills required, and here/how to find them.Presented by: Arthur Brandwood & James Morrison

FDA has announced broad reaching initiatives to update the 510(k) program and leverage international practices and requirements. This brings real opportunities for international firms to make much greater use of their non-US regulatory data to gain FDA approvals.Join T.J. Thiel and Jean Nicolas Boudaud to provide guidance in navigating the FDA’s submission process uses for your company’s international regulatory work. T.J. and Jean will discuss the numerous pathways for FDA approval as well as how these relate to the international (including TGA, Health Canada and EU) regulatory activities. This webinar will help understand the current synergies but also focus on the opportunities for harmonization.

In September 2018, ISO published the long-awaited 5th Edition revision to ISO 10993-1. This update firmly brings biological evaluation into a well-developed risk management model, where the knowledge of device materials and chemistry becomes the central starting point and biological testing follows on only when it’s necessary to fill gaps in knowledge.The famous Table A1 “checklist” has been updated and now is in close agreement with the FDA biocompatibility guidance.Join James Morrison for a deep dive into the new ISO 10993 part 1, and learn why biocompatibility must be based upon knowledge of materials, and how to minimise costly biological testing. James has been an active member of the ISO Technical Committee and been a key contributor to the development of the ISO 10993 standards. You won’t want to miss this one.

In this episode we take an updated look at the recent TGA announcement that the agency is expanding its recognition of international medical approvals from the current reliance on CE certificates – to utilise device approvals from the USA, Canada or Japan for ARTG registration. This is particularly important news given the current MDR tribulations in Europe and offers manufacturers welcome new alternate pathways to Australian registrations.