No matter the risk management question, Edwin Bills will likely have the answer. He's been involved in the medical device quality and regulatory space for many, many years. Give him a tricky compliance situation or example, and chances are he has been there and done that, maybe more than once.

Ed sat down with Michelle to talk about ISO 24971, MDR and the risk of radiation exposure in a sun-filled hospital room.

All You Ever Wanted to Know About Risk Management with Edwin Bills

Determining which FDA submission pathway best applies to your medical device or product can be daunting. Listen in as Michelle explains how to decide if your product qualifies for a 510(k), PMA, de novo or 510(k) exempt submission - as well as the basic requirements for each.

FDA Submission Pathways with EIT Health Alumni

Does regulatory strategy really impact your business strategy? Yes! Stephanie Schull, founder of kegelbell, explains how defining the regulatory strategy for her fledgling business early on helped promote her product both to investors and distributors around the globe.

How A Strong Regulatory Strategy Can Boost Your Business with Stephanie Schull

More and more women are investing in medtech startups as the next phase of their professional development. 

It's a key career move that can fuel further business growth while establishing women entrepreneurs as experts and investors to be taken seriously.

But all investors need to know what to look for when gauging a pitch from a startup, because it's not just about the cool new science or the revenue projections. 

My friend and mentor Faz Bashi taught me a thing or two about investing, and has been working to educate and empower other women looking to take this important professional step.

Empowering Female Entrepreneurs and Investors with Faz Bashi

Whether you are an investor or inventor/founder, there are some things you need to avoid if you want your FDA submission to succeed, some common regulatory mistakes that a lot of startups make. 

These common misconceptions about the FDA submission process can cost you time and money and extend your go-to-market timeline, so it's worth knowing how to avoid them.

The FDA No Good Very Bad Day: Common Regulatory Mistakes

It used to be that Europe was the first choice when bringing a product to market. Relaxed regulation meant a quick approval and the chance to earn some money while waiting for FDA approval. That's not the case anymore, and thanks to MDR, there are new challenges and roadblocks - not to mention a LOT more expense - involved in bringing a medical device to market in Europe.

The MDR No Good Very Bad Day: Go To Market Challenges in the EU

We all knew that MDR would change the medical device industry forever, hopefully for the better. But as manufacturers grapple with redundant requirements and notified bodies struggle to attract and retain the qualified staff mandated by the new regulation, it becomes clear that MDR is not just changing the medical device industry - it's requiring an entirely new mindset.

EUDAMED, MDR and Other Madness with Richard Houlihan - Part I

This is the second part of my conversation with Richard Houlihan, where we delve into the current status of the EUDAMED database, the intricacies of the data entry process, and why the EU competent authorities are not your friends.

EUDAMED, MDR and Even More Madness with Richard Houlihan

It's no longer a secret that MDR has morphed into an unmitigated disaster for the medical device industry - and Michelle has the goods to prove it. In this first in a series, she spills the beans on notified body readiness, the roadblocks that have been causing the most trouble, and the FDA's long-term plan to become the easier pathway to market.

The Aftermath of MDR - Part I

Six months into MDR and manufacturers and notified bodies are clashing over differences in opinion and fighting over their respective interpretation of the standards in pursuit of product certification.

In this second installment of a series, I share three real-world examples of what actual clients faced when going through the MDR certification process.

You'll want to listen and learn from their experiences, so you'll be better prepared for your boxing match with your notified body.

The Aftermath of MDR - Part II

In this final segment from 𝗧𝗵𝗲 𝗔𝗳𝘁𝗲𝗿𝗺𝗮𝘁𝗵 𝗼𝗳 𝗠𝗗𝗥 webinar, we discuss what you should and should not do when preparing for your certification, then segue into what you need to consider when building the business case for (or against) pursuing certification.



This one runs a bit longer than 15 minutes because it includes most of the Q+A session, and that has some juicy tidbits you don't want to miss.

The Aftermath Of MDR - Part III

Mitch Robbins is moving on, and Michelle Lott of lean RAQA will be taking over the podcast! Mitch and Michelle chat about transitioning the podcast, what's ahead for the Anthony Michael Group, and what the leanRAQA team has in store for 2021.

RAQA Today Becomes leanRAQA Today: What's Next?

You have a raw material supplier. You have a marketing strategy. You have a sales funnel. But what you don't have is a clear understanding of the regulatory requirements for this new surgical mask you're making.

Now what? Do you even know where to start?

Michelle sits down with a client facing this dilemma and walks her through the regulatory process and requirements for a "simple" surgical mask. (Hint - there's no such thing).

Regulatory Requirements and the "Simple" Surgical Mask

Protective gear is still in high demand, and absolutely everyone is making masks. In this April 2020 clip from Joe Hage’s weekly COVID-19 call, I discuss the requirements for each type of mask, the constantly changing regulations, and the reason why that homemade mask may not offer up any protection after all.

PPE, Masks and FDA Regulations in the Age of Coronavirus

Have you ever struggled to understand the regulatory difference between a product, an accessory and a component?

Have you ever driven yourself slightly mad trying to determine the best FDA submission pathway for that product, accessory or component?

A group of medical device manufacturers asked those very same questions during a presentation I gave in the fall of 2020. 

The answers apply to more than just ventilators, so there is something in this video for just about everyone.

If you want to view the video version with the slide deck, check it out on my YouTube channel: https://youtu.be/e-UTXSFwHaw

Enjoy!

Ventilators, Components and Accessories - Choosing the Right FDA Pathway for Your Product

In this clip from Elemed's Entrepreneurial Roundtable series, Michelle sits down with Monir El Azzouzi, Stefan Boelleininger and Elena Kyria to talk about the benefits and challenges of running your own business.

You can hear the entire discussion at http://www.elemed.eu/mentoring

Entrepreneurial Roundtable with Elena Kyria

Robert has years of experience working for notified bodies, and provides a peek behind the curtain at the North American division of Norway's DNV GL Presafe. Hear what they have going on now, what may be coming up in the future, and how a notified body determines how to best manage a client project.

Note: You didn't miss anything, and your headset did not malfunction. We removed all references to other notified bodies from the podcast, but decided not to annoy you with the delete beep.

Inside a Notified Body with Robert Dostert

The recent FDA device downclassification decision is not good news - for industry or for patients. Several devices on this list - namely ventilators - have benefitted from close FDA scrutiny during the 510(k) submission process. They are safe precisely because they have been so closely regulated, not because they are simple to use and present limited risk to the patient.

This podcast combines three different interviews into one narrative about the FDA decision, the reasoning behind it, and the action we need to take to keep ventilators and other devices under the careful watch of federal regulations.

Link to the original post and instructions for submitting your comments to the Federal Register: https://leanraqa.com/regulatory-quality/fda-down-classified-classification/

FDA Device Downclassification - This is Not Good News

Are regulatory and reimbursement at all related? Does one influence the other? Or are they more like oil and water, both necessary but not really something you should mix?

Michelle and Nic Anderson answer questions about how regulatory and reimbursement issues can impact a product's go-to-market strategy, and how these two seemingly disparate areas actually may overlap in a variety of medical device scenarios.

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