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.

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.

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.

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.

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/

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.

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

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!

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.

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).