The good folks at Vistatec invited me to participate in their Life Science In-Focus podcast last month, where host Karen Tkaczyk and I chatted about the intricacies of regulatory affairs within the life sciences.We also discussed just how I e

eSTAR 5.0 - What You Must Know

Apr 19th, 2024 32m 58s

This is not last year's eSTAR - a LOT has changed, and there are things you need to know before you try to submit your 510k. In this episode, we'll guide you through the intricacies of the latest eSTAR 5.0 platform, crucial for those of you p

The Benefits of 3rd Party FDA Reviewers

Mar 12th, 2024 37m 6s

Why would you use a 3rd party reviewer for your submission? How does a 3rd party reviewer function? How is it different from working with the FDA?I sat down with my good friend Shawnnah Monterrey from Beanstock Ventures to answer all your pre

eSTAR 5.0 Q+A with Patrick Axtell from the FDA

Feb 20th, 2024 33m 52s

Question, questions, everyone has questions about eSTAR 5.0, so I sat down with the FDA's Patrick Axtell to answer the most pressing ones I've received.From file size to eSTAR type to biocompatibility - we cover it all.

Fractional or Full Time Quality Support: Which is Right for You?

Feb 7th, 2024 22m 49s

When is it better for a medtech startup to hire a fractional quality professional, and when is it time to hire full-time? This is not necessarily an easy question to answer, and there can be a lot of factors impacting the decision. In this

Medical Devices, Cloud Computing and Cybersecurity with Randy Horton

Nov 29th, 2023 27m 56s

As medical devices become more connected, concerns about security increase, leaving manufacturers - and regulatory staff - uncertain as to the best path forward. Listen in as Michelle and guest Randy Horton discuss industry needs and what the F

The Business Benefits of Quality

Aug 11th, 2023 12m 12s

Many manufacturers see quality as a necessary evil, a box to be checked just to placate the FDA on the way to market launch. But it can be SO much more.In this episode, Ti Benson and I discuss how quality can actually be a business benefit an

The Joy of Document Control

Aug 9th, 2023 15m 29s

You may think document control is boring, but wait until you hear these stories:Red-lined post-it notes. Uncontrolled copies passed around during inspections. Master files stored on a desktop instead of in the eQMS system. Secret file cabinet

Make Quality Make $en$e: Management's Role in Quality

Jul 31st, 2023 37m 27s

The best leaders know that quality is much more than a box to be checked, or a necessary evil to be endured along the road to FDA (or MDR) approval.This is the third in a series of conversations talking about quality and how it can actually b

MDR By The Numbers: Leveraging New Data for Implementation Planning

Mar 10th, 2023 1h 18m

MDR has been puzzling me for a few years now, and it's getting worse, not better. In this webinar hosted by Greenlight Guru, we look at the data gathered from recent MDCG guidance documents, industry and notified body surveys, and personal inte

EUDAMED Update: January 2023

Feb 21st, 2023 51m 47s

Upload to EUDAMED is a requirement of MDR, but adoption has been slower than anticipated. Manufacturers are reluctant to invest in the time required to upload their product catalog, and the platform itself has been plagued with issues. Listen i

From the Front Lines of EU Medical Device Regulation

Jan 31st, 2023 1h

What happens when two regulatory consultants sit down for a chat about MDR?A lot of distressed head shaking, for sure and an equal measure of what-were-they-thinking eye rolls, but we also dug into the meat of the proposed extension and what i

Risk Management - Beyond the Basics

Dec 13th, 2022 54m 31s

Risk management can be difficult to understand, even for seasoned quality and regulatory professionals, because there are SO. MANY. ACRONYMS.I mean, there's FMEA, uFMEA, ISO, FDA, PMA to name a few.We discussed acronyms and more at the Nove

Trends in FDA Initiatives and the Impact on Orthopedic Devices

Nov 15th, 2022 38m 14s

Orthopedic devices may qualify as medical devices, but they have very different regulatory requirements. So different that the FDA created a new office to manage orthopedic devices - the Office of Science and Engineering Laboratories (OSEL) - a

Free FDA Communications with the FDA? What you Need to Know

Nov 8th, 2022 50m 9s

There's the pre-submission, of course, but did you know there are other ways to get FDA feedback without breaking the budget? In this episode, Michelle reviews three pathways that can help startups save some cash while working their way through

Split Personalities of QMS Audits for FDA, MDSAP and ISO 13485

Oct 31st, 2022 50m 51s

Similar but different is a good way to describe how FDA inspections and MDSAP and notified body audits compare. On the surface, they appear to be looking at the same things, but dig a little deeper and the differences in agenda - and outcome -

Usability Testing and the FDA

Oct 25th, 2022 32m 35s

Do you know how your end users will use your device? Are you sure?Do you know how end use will differ between demographic groups? Do you know why this is important, and how usability testing fits into your risk assessment?Shannon Clark has be

Is your State of Affairs for MDR State of the Art?

Oct 17th, 2022 1h 3m

If you're struggling to determine whether your devices qualify as state of the art - and how that can impact your submission strategy - then check out this presentation I did with my friends at Greenlight Guru in August.Etienne Nichols and I

MDR, FDA and Other Regulatory Realities

Sep 22nd, 2022 35m 41s

When submitting a medical device for regulatory approval, it's always better to just dive in, accepting the fact that it's going to take a lot of work and require a lot of patience before you feel the glow of market clearance or approval.Ther

Digital Health: The Future of Medicine and Medical Devices

Sep 13th, 2022 43m 14s

Digital health technologies are exactly new, but they did get a huge boost from COVID and will define how we deliver healthcare in the future. Digital health includes telemedicine, software functions that allow providers to monitor patients r

The End of the COVID-Era EUAs

Sep 6th, 2022 42m 9s

The end of the COVID-era emergency use authorization (EUA) is rapidly approaching - do you know what's next?Earlier in the year, the FDA laid out their proposed plans for transitioning devices marketed under and EUA or FDA enforcement policy

Crash Course in FDA Submissions

Aug 31st, 2022 25m 10s

So - you have a product, and you have a submission ready to go to the FDA. You're all set, right? You know how the e-Submitter works, you know exactly what FDA Form 3514 is for, and you know the best questions to ask the FDA during your pre-sub

Five Steps to Bring a Medical Device to Market

Aug 23rd, 2022 29m 22s

So - you're a hot new startup with a snappy new medical device. Now what? Do you have an intended use statement? Do you have the 𝘳𝘪𝘨𝘩𝘵 intended use statement? Do you know for sure that your product qualifies as a medical device? What a

Design Controls and Risk Management

Aug 17th, 2022 1h 19m

Which comes first - design controls or risk management? Both - because the two are inextricably linked. In this podcast, we'll take an in-depth look at both design controls and risk management, the waterfall design process, how/where risk manag

Breakthrough, de novo, or PMA? FDA Submission Pathways for Novel Devices

Aug 9th, 2022 47m 59s

You've developed a novel technology and want to bring it to market in the US. Now what? Can you submit as a breakthrough device, or is the de novo route a better choice? How are they different? How are they similar? Breathe - and listen in as