RAQA Today

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!

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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.

LinkedIn: https://www.linkedin.com/in/michellelottraqa

Website: https://leanraqa.com/

YouTube: https://www.youtube.com/@leanRAQA

Instagram: https://www.instagram.com/leanraqa

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.