RAQA Today

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!

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 benefit a company, and even give you an advantage over your competition.

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 interviews with stakeholders (including notified bodies) who shared their first-hand experiences with implementation (spoiler alert: it ain't pretty).

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 in as Richard Houlihan lifts the curtain on why industry has been reluctant to embrace EUDAMED and what the future might hold for both sides.

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 it might mean for industry. Monir El Azzouzi and I chatted last month about MDR, and while we didn't solve all of the EU's problems, we did touch on some of the biggest challenges facing manufacturers.

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 November meeting of the Dallas ASQ - Section 1402, so if you're ready to go beyond the basics and right into the very heart of risk management, then this is the podcast for you.

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) - and ensure their safety and efficacy. OSEL was created to accelerate patient access to innovative devices, as was the Orthopedic Devices Program. In this podcast, Michelle walks through the important work that OSEL is doing and the regulatory specifics you need to know when preparing the submission for your orthopedic device.

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 the commercialization process.

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 - become plain.

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 been doing human factors/usability testing for some time, and she can tell you exactly why usability testing is required and the impact it can have on your final product design.

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 sort through all the acronyms - SOTA, SOC, MDR, MEDDEV, IVDR - and try to shed some light on what MDR says about state of the art, what it doesn't say, and how to determine your best path forward.

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. There are just SO MANY things to consider, and remember, and document, and SO MANY regulations to refer to on both sides of the Atlantic. In this edited version of a Greenlight Guru podcast from earlier this year, I discuss the roadblocks that exist on both sides of the Atlantic with Jon Speer and Etienne Nichols - and share what you can do to make sure you don't end up with an MDR or FDA-induced hangover.

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 remotely, apps that track medication use and provide user-configured reminders for improved compliance - and more. In this podcast, we dive into the whys and the hows of regulating digital health while still managing to bring products to market.