Podcasts about pm as

Roxanne Dubois has represented medical device companies as the primary liaison with the FDA and Notified Bodies for over 25 years. Roxanne forms collaborative working relationships with representatives of regulatory agencies to obtain clearance/approval for 510(k)s, IDEs, PMAs, and Design Dossiers for new medical devices and device modifications. Roxanne has hands-on experience writing regulatory applications (including three Original PMAs), responding to Agency questions and meeting in-person and by teleconference with FDA representatives. Roxanne’s experience also includes initiation of Quality Systems for start-ups, approval of new manufacturing facilities and facilitating on-site inspections by Regulatory Agencies (QSR, BIMO, pre-PMA, new facility and inspections by Notified Bodies and a Competent Authority). While mostly focused on Regulatory and Quality, she also has experience with Clinical Affairs and combination products.Roxanne has served as the VP of Regulatory Affairs and Quality at SI-BONE, VP of Regulatory Affairs at Tenaxis Medical, VP Regulatory Affairs and Quality Assurance at Carbylan BioSurgery, Inc., VP Regulatory Affairs, Clinical Research and QA at ReGen Biologics and also as the Director of Regulatory Affairs at several mid-sized companies including Kyphon, Collagen Corporation and Cohesion Technologies. She has also consulted for medical device companies in a variety of fields such as orthopedic, gastroenterology, women’s health, dental and cosmetic surgery. Roxanne has a Bachelor of Science in Biochemistry from Cal Poly, San Luis Obispo.Roxanne's Contact information:m: 408-828-5019e: rduboisconsulting@gmail.com

It's all PMAs today

PMAS! PATRICIA MASON!It's YOUR Wednesday night conversation! It's the night before Halloween! Mister USofA MI Classic Freddy Prinze Charming and Felicia Minor are joined by the recently crowned Miss Gay Metropolis America Patricia Mason! Live-streaming at 8 p.m. Arizona time on the Facebook page! Special thanks to all of you who subscribe to our Patreon at patreon.com/letshaveafefe. Promotional consideration for this season of Let's Have A Fefe with Felicia "Fefe" Minor & Freddy Prinze Charming by Marissa Sanchez & Wigsofakind and The Burly Barber.

If you haven’t realized it yet, risk management in the medical device industry isn’t going away. How do you navigate, capture, and document when and what to do? In this episode, Jon Speer invites guest Mike Drues of Vascular Sciences to join the show as the two discuss FDA’s two, new guidance documents that provide additional transparency, consistency, and objectivity regarding benefit-risk determinations. Some of the highlights of the show include: ● Differences between Documents: Under what circumstances that pose a greater risk are acceptable for product submissions vs. appendices related to ISO 14971. ● New nine-page benefit-risk assessment worksheet is oversimplified and presents a non-traditional instead of analytical approach to determining benefit-risk. ● New guidance documents don’t mention 510(k) device, but why? People should already know about uncertainty and risk of 510(k) medical devices via predicates. ● Higher risk is acceptable in various classifications of medical devices, including PMAs and BDPs, and when dealing with small populations. ● Adding to the complexity of medical devices, the guidance documents now include low-, medium-, and high-risk categories and criteria of uncertainty. ● Pay attention to patient’s perspective of uncertainty when available. Are patients willing to truly accept risks and uncertainty to achieve unmet clinical need? ● Mitigate uncertainty in other ways, such as through labeling, degree of need, and clinical evidence/market data of product. ● Probable Benefit of HDE: Efficacy at a lower statistical power may diminish uncertainty due to giving patients early access to a medical device.

SUNDAY, 06/09/2019 PM: As a Christian, your spiritual victory largely depends on the thoughts of your mind. The post A Timeless Filter for Our Thoughts appeared first on Anthony Baptist Church.

Are you confused by regulatory terminology? Clearance. Approval. Granted. Do these terms matter or make a difference when it comes to medical devices and working with the FDA? Yes, they do! Mike Drues of Vascular Sciences joins me to talk about the differences between clearance vs. approval vs. granted, which are the three most common ways medical devices are brought to market. Some of the highlights of the show include: ● Clearance: When a 510(k) is cleared from the FDA. Approval: When a PMA is complete. Granted: When a De Novo is complete by the FDA. ● There are reasons to get angry when medical device companies use incorrect terminology. What other mistakes might they be making? ● Riegel v. Medtronic Case: U.S. Supreme Court held that the level of safety and effectiveness of a PMA medical device is higher than a 510(k). ● There are pros and cons to each pathway. Know all your options because 510(k) is not necessarily the best. ● Companies should not avoid PMAs as a convenient excuse because they think extra time, work, risk, and investment are involved. Instead, pursue them. ● The safety and effectiveness of a medical device is never dependent on whether it is cleared, approved, or granted. So, set the bar high on its worthiness.

How do you feel about pre-market approval (PMA) for Class III medical devices? Most businesses are not excited about products that require a PMA. But don’t look at it as the Kiss of Death. Embrace the PMA concept as a way to bring novel and unique devices to the market. Mike Drues of Vascular Sciences and I explore the topic of PMA. Lives depend on it! Some of the highlights of the show include: ● Efforts are being made to entice acceptance of PMAs by requiring less clinical data and testing to get devices on the market sooner for customers. ● Class III medical devices are often those that are life-sustaining, and making them safe is critical. ● Questions to consider: What is safety? How safe is safe? How much testing is enough? ● FDA has an initiative to promote innovation and for companies to bring products to market in the United States. ● Industry statistics show that reporting issues may not be done or delayed when there are problems and malfunctions with devices; deadlines may be extended. ● When you learn of problems with a device, you have a professional and ethical obligation to investigate and resolve them. Don’t just put a Band-Aid on it! ● Finding a new PMA pathway: One way for novel devices and one way for me-too devices ● Take a risk-based approach to regulations and value predicates.

When developing a new medical device, do you try to figure out the fastest and simplest way to get your product to market? As a product developer, do you explore a regulatory path? Or, are you afraid that may kill your idea? Mike Drues, president of Vascular Sciences, is with us today to do some premarket approval (PMA) myth busting and describes why a PMA path may not be as scary as you think. Some of the highlights of the show include: ● PMAs are reserved for the highest risk devices (Class III and life-supporting). ● Utilize the patient-centered approach because assumptions are often made about risks and invasive vs. non-invasive devices. ● Can you use a predicate to show substantial equivalence for a PMA device? From a regulatory perspective, there is no concept of substantial equivalence. ● Use the MAUDE database and identify any precedence that has been set to gather knowledge about devices you are developing. ● You have a story to tell. Be able to explain your product, position, and why your product is good for the patient. ● All PMAs require clinical data. False! The vast majority of PMAs do require clinical data, but some PMAs do not require such data. ● What are the pros and cons of a PMA vs. a 510(k)? Most opt for a 510(k). ● Class III devices can do a PMA, or other options, including the Humanitarian Device Exemption (HDE) and Product Development Protocol (PDP).

Good afternoon, Kia here with another Hezekiah moment.Today we'll talk about briefly Major Alonzo Byrd Jr.  His show is being aired live on Friday February 5, 2016 at 9 PM and you're not going to want to miss this show. I want to first thank my good friend Ms. Joi Ford for telling me about this amazing young man.  She told me in the beginning of this new year that I should have him on the show, and me being one that listens, I called him up last weekend, and he was obedient to the call and said yes, and I'm truly excited to have him on this week.   Also, we'll have another treat as well, since our regular co-host Nichelle Johnson is still taking her well needed vacation, I've asked another good friend of ours to help out this week, and it's none other than Deacon Thomas Farr of "Issues" Christian Men Talk. So we are just going to have a great time in the Lord this Friday night. A little about Major Alonzo Byrd.  He was about 6 or 7, when he began to sell comic books. Next, he opened his candy business. Then, he sold magazines, school supplies, and fireworks. He was that “go-to-guy” for supplies, and that lasted until he was 15, and able to work. He shoveled snow, mowed lawns, and washed cars. He wished he'd never stopped, because of the freedom and ability to control his own destiny. He wished he learned the principles in his book 24 years ago! he wished someone taught him what he is missing today.  YUP, Young, Unique, And Paid! 10 Entrepreneurial Keys for Kids is his contribution to the younger generation, from being an entrepreneur since the age of six, he wants our young people to understand that, yes, I'm young, but guess what, I can get paid! So join us on The Man In The Mirror Friday night at 9 PM As we welcome Major Byrd to the show.

Aug 9, 2015 12:00 PM "As we ponder our path as it instructs us to do in proverbs 4:20-24, God is going to show us things that he wants us to work on. These things represent some course corrections that will help steer us away from disasters in our lives. In a way we are a "Fluid Concept" to God."

Mar 9, 2014 12:00 PM "As we continue our 'Transformed Life' teaching series, Don expounds on the subject of Christian maturity. What does it look like to be mature in our faith? How can a mature faith lead to a transformed life? Join us for the sixth installment in our teaching series!"

Mar 23, 2014 12:00 PM "As we are seekin transformed life in Jesus, we ask 'How is a person transformed?' Join us as we journey through the scriptures and church history to learn about the transformation of the heart."

Apr 27, 2014 12:00 PM "As part of our transformed life series, Don presents a Biblical world view of the difficult and sometimes uncomfortable topic of sex and its relation to the transformed life we have in Jesus."

Aug 5, 2012 12:00 PM "As our church is looking to begin a new chapter, Pastor David addresses what the Bible says about the role of Elders and Pastors."

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