RAQA Today

Which market is best for your product - the EU or the US?

The answer is not always straightforward, but Ronald Boumans, Nika Mendelev and I did our level best to answer your questions in this Master Class presentation.

Michelle leads off with a review of FDA strategies and pathways.

15:34 - Ronald dives into the particulars of MDR and dealing with notified bodies.

27:15 - Nika Mendelev explains whether you really need to choose one or the other.

32:10 - the Q+A session begins.

Link to the full presentation on YouTube: https://youtu.be/4wyZzVibiAY

Biocompatibility testing is hot right now, in part because of the sharp increase in the number of FDA submissions containing fraudulent data. Some unethical third-party testing labs are sending their clients data mined from old 510(k) submissions - and passing it off as fresh data.

So what's a medical device manufacturer to do? That was the topic of conversation this month when I chatted with Mike McGrew and Sandi Schaible from WuXi AppTech.

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 ended up in the field, and the many challenges companies face when choosing regulatory pathways in the United States and Europe.

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 planning a 510k or PMA submission.

We'll review the eSTAR 5.0 platform and what you need to know to use it effectively –the good, the bad, and the ugly.

The new features, including premarket approval content and updated cybersecurity documentation and dive into the simplified EMC questions, revised sterility section, and new biocompatibility testing options - we'll cover it all.

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 pressing questions about using 3rd party reviewers.

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.

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 joint podcast with Mitch Robbins, we discuss the challenges and opportunities of today's topsy-turvy QA hiring market, and why many companies are opting for fractional QA professionals rather than full-time employees.

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 FDA plans to do to ensure the safety of connected and AI-driven devices.

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 and not simply something to be endured.

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 cabinets in locked closets full of uncontrolled, red-lined specifications documents.

Oh, the joy of document control!