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.
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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
Michelle was invited to speak to the Southern California chapter of Opthalmic World Leaders (OWL) and familarize them with the basics of the approaching MDR transition.
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).
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.
Bryan Brosseau, the Founder of Brosseau Consulting, joins us for an interesting conversation regarding the Dark Corners to watch out for in RA/QA.
Bryan has built a storied career in the RA/QA functions working his way up to the VP of RA/QA spot before building a successful consulting business. At Brosseau Consulting, Bryan and his team provide quality and regulatory services for the medical device and biologics industries. They help companies access new markets, instill culture of quality, and ensure regulatory compliance.
Too often, RA/QA is either not brought into critical decision making conversations early enough or not at all. These mistakes end up costing companies in time and missed revenue by having to go back and remediate situations that could have been avoided in the first place.
Listen in as Bryan shares his experience and advice to Founders, CEOs, and other Execs who's ultimate RA/QA decisions impact the entire organization.
Adam Saupe, Sr Talent Advisor at The Anthony Michael Group, and I bust some recruitment myths prevalent in today's COVID-19 environment.
Tune in as we cover a wide array of topics such as:
The current state of hiring in the Med-Tech space
Why NOW is the time to be proactive with your career
What companies are doing, or should be doing, as it relates to EU-MDR changes
.....and much more
Andy Pal, Associate Director of Software Development at Quidel, joins us with over 20 years of Software development experience across a wide array of industries. Quidel is a California-based leading diagnostic healthcare manufacturer serving to enhance the health and well-being of people around the globe through the development of diagnostic solutions that can lead to improved patient outcomes and provide economic benefits to the healthcare system.
-Gaining trust and respect vs obedience from your team
-Why performance reviews AREN'T the time to communicate important feedback
-How to make the transition from "technician" to leader
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Bartell and Bartell is a "people operations" partner. This company, a leadership development and technology firm, for over 40 years has partnered with thousands of leaders across the world to help lay the foundation to unleash the potential from Human Capital.
People, as we know, make or break an organization's success.
Today we discuss how to drive peak performance from your leadership teams and the staff they lead.
To aid in the discussion, I was joined by Mr. Shawn Ishler, Director of Client Services, and Ms. Tara Arnold, Director of Business Development both of whom have outstanding tenure with Bartell and Bartell and have driven amazing results for so many organizations and leader's alike.
Tune in to hear what they have to say!
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Such a great episode with Molly talking about her "Say it Skillfully" Movement. Helping business leaders learn how to effectively communicate through humility, honesty, and genuine care and compassion.
Molly has a storied career.
She earned her Bachelors degree in Chemical Engineering from Cornell University and her MBA from UCLA.
Molly is a Certified Executive Coach through the Marshall Goldsmith program.
She spent 20 years at Cisco leading a variety of functions to include Operations, Marketing, and Consulting.
Back in 2014 she started her own Consulting organization, Abella Consulting which helps Executives skillfully interact as one cohesive unit and learn how to be committed to each others' successes as much as their own.
Listen in as Molly shares so many great nuggets you can utilize in your business immediately.
Deborah Hiner, President & CEO of Deborah Hiner Consulting, joins us today to discuss critical strategies Med-Tech, Digital Health, & Diagnostics organizations can implement when in very early phases of building out the team. When you need to run lean, but need the fuel (talent) to drive business, these are the recruiting strategies that will help.
For over 15 years, Deborah has built a career in helping organizations, both billion dollar companies and young, aspiring startups, to scale by building high-performing teams.
The majority of her experience is centered in the Life Sciences.
At the heart of her efforts, are the principals of performance based hiring.
Check out this episode to learn the vital recruitment strategies you can implement in your start-up Med-Tech business today.
Joining us on this episode is Ms. Jessica Burger, Sr. Global Clinical and Regulatory Compliance Specialist at CooperVision.
If you are unfamiliar, Coopervision with headquarters in Pleasanton, CA, is one of the world’s leading manufacturers of soft contact lenses and other related products and services.
Jessica started her career in the Life Sciences industry approximately 10 years ago as a Microbiology Technician and then as a Microbiologist. In 2013, she made the transition into Regulatory Affairs at Bausch & Lomb and has progressively moved her way up the ladder having held various roles including Specialist, Sr. Specialist, and now in her current Sr Compliance role.
She holds her bachelors degree in Biology and her Masters in Business Administration.
Some highlights from the show:
-Risks/Milestones that helped Jessica get to where she is today and advice she’d have for others in a similar spot
-Her opinion on the future of what Regulatory looks like
-Why she thinks it’s so important to be a subject matter expert, what that means, and how you can do the same….
…and so much more!
Monir El Azzouzi is the founder of Easy Medical Device. Easy Medical Device is a platform dedicated to informing the public about medical device standards and regulations across the world.
Monir has a tenured background in the Medical Device space having started out as a Biomedical Engineer and taking on progressive levels of leadership in Regulatory Affairs and Quality with organization such as Johnson & Johnson, Bausch & Lomb, and B. Braun.
He comes to RA QA Today to discuss a huge industry "hot button"...that of the current Notified Body situation in the EU.
Today we roll out another RA/QA Today podcast episode, but this one is different from any of the others released thus far.
Mr. Eli Ketchum, Global Regulatory Director for Personalized Healthcare at Genentech was our first guest as a part of our Elite Escalator Mini-Series.
We have decided to create a mini-series with Technical Professionals (RA/QA/Engineering, etc) guests who are considered to be "rising stars" in their functional area.
They are knockin the cover off the ball, consistently finding ways to shine and "climb the ladder".
Some highlights from our show with Eli:
-How and why it's important to be comfortable with being uncomfortable
-Keys to his success to-date and how you can implement the same strategies
-Keys to staying motivated and passionate
..and so much more