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Content provided by RQM+. All podcast content including episodes, graphics, and podcast descriptions are uploaded and provided directly by RQM+ or their podcast platform partner. If you believe someone is using your copyrighted work without your permission, you can follow the process outlined here https://player.fm/legal.
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Live! #34 — Optimizing Technical Documentation to Reduce Notified Body Review Time and Questions (Devices & IVDs)
Manage episode 291933581 series 2688337
Content provided by RQM+. All podcast content including episodes, graphics, and podcast descriptions are uploaded and provided directly by RQM+ or their podcast platform partner. If you believe someone is using your copyrighted work without your permission, you can follow the process outlined here https://player.fm/legal.
This is the audio-only version of RQM+ Live! #34, originally recorded May 6, 2021.
We all have the same goals when submitting technical documentation to the notified body for review:
- Minimize questions
- Minimize deficiencies
- Achieve certification
There are many strategies to improve your odds, and this panel of experts knows them well. We'll discuss the easy solutions, such as simply using terminology and organizing your file in a way that the notified body reviewers expect. This may sound obvious, but we've all worked at manufactures who wanted their regulatory files to be different than recommended.
We'll also discuss more complicated but necessary strategies, like telling a consistent story of clinical evidence across promotional claims, risk management, clinical evaluation, and post-market surveillance.
Many of us like to use the metaphor that while you may all be wonderful singers individually, if you are each singing from different sheet music... well, it will sound awful to the audience.
This panel of subject matter experts includes our esteemed former notified body leaders as well as our seasoned regulatory professionals who have created many MDD and MDR technical documentation files. No matter how long you've been in the industry, we believe that you'll leave this discussion with some new tips and tricks to take back to your team.
Panelists:
- Jaishankar (Jai) Kutty, Ph.D. - VP, Clinical Regulatory Services
- Nancy Morrison, RAC - Executive Director, Regulatory and Quality Consulting Services
- Ruthanne Vendy, RAC - Senior Principal Specialist
- Melissa DeHass - Senior Regulatory Specialist
-
About RQM+
RQM+ is the world's leading medical device and diagnostics focused regulatory and quality consulting firm. We deliver transformative solutions by providing an unrivaled collective expertise, fueled by passion for client success. Our experts are collaborative, laser-focused on client needs, and committed to delivering high value solutions that exceed expectations. Learn more at RQMplus.com.
--- Send in a voice message: https://podcasters.spotify.com/pod/show/deviceadvice/message136 episodes
Share
Manage episode 291933581 series 2688337
Content provided by RQM+. All podcast content including episodes, graphics, and podcast descriptions are uploaded and provided directly by RQM+ or their podcast platform partner. If you believe someone is using your copyrighted work without your permission, you can follow the process outlined here https://player.fm/legal.
This is the audio-only version of RQM+ Live! #34, originally recorded May 6, 2021.
We all have the same goals when submitting technical documentation to the notified body for review:
- Minimize questions
- Minimize deficiencies
- Achieve certification
There are many strategies to improve your odds, and this panel of experts knows them well. We'll discuss the easy solutions, such as simply using terminology and organizing your file in a way that the notified body reviewers expect. This may sound obvious, but we've all worked at manufactures who wanted their regulatory files to be different than recommended.
We'll also discuss more complicated but necessary strategies, like telling a consistent story of clinical evidence across promotional claims, risk management, clinical evaluation, and post-market surveillance.
Many of us like to use the metaphor that while you may all be wonderful singers individually, if you are each singing from different sheet music... well, it will sound awful to the audience.
This panel of subject matter experts includes our esteemed former notified body leaders as well as our seasoned regulatory professionals who have created many MDD and MDR technical documentation files. No matter how long you've been in the industry, we believe that you'll leave this discussion with some new tips and tricks to take back to your team.
Panelists:
- Jaishankar (Jai) Kutty, Ph.D. - VP, Clinical Regulatory Services
- Nancy Morrison, RAC - Executive Director, Regulatory and Quality Consulting Services
- Ruthanne Vendy, RAC - Senior Principal Specialist
- Melissa DeHass - Senior Regulatory Specialist
-
About RQM+
RQM+ is the world's leading medical device and diagnostics focused regulatory and quality consulting firm. We deliver transformative solutions by providing an unrivaled collective expertise, fueled by passion for client success. Our experts are collaborative, laser-focused on client needs, and committed to delivering high value solutions that exceed expectations. Learn more at RQMplus.com.
--- Send in a voice message: https://podcasters.spotify.com/pod/show/deviceadvice/message136 episodes
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Similar to Device Advice by RQM+
The Partnership Economy explores the power of partnerships through candid conversations and stories with industry leaders. Our hosts, David A. Yovanno, CEO and Todd Crawford, Co-founder, of impact.com, unpack the future of partnerships as a lever for scale and an opportunity to put the consumer first.
…
continue reading
It didn’t all change in March 2020. Not really. The UK high street has been in the throes of a gradual revolution for decades. From the rise of ecommerce, to the birth of mobile, social commerce, and a growing emphasis on experience, change has been underway for a while. In fact for many, the pandemic has acted as a wake-up call. Digital transformation was no longer a ‘nice to have’ but a matter of survival. Necessity sparked innovation and customers are enjoying more flexibility and conveni ...
…
continue reading
Ever wondered what makes great go-to-market leaders grow, even when the going gets tough? We have, too. And we’re on a mission to uncover the magic that makes that growth happen. This is Go-to-Market Magic, the show where we talk to go-to-market leaders and visionaries about the “aha!” moments they experience and the pivotal decisions they’ve made, all in the name of growth. And we’re not just talking about revenue growth that goes up and to the right — we’ll also discuss how they improve th ...
…
continue reading
A bootstrappers podcast for founders, entrepreneurs, visionaries and dreamers who are building businesses from the ground up without the taking on debt or selling equity. Here we cover marketing, sales, organization and mindset issues that matter to you
…
continue reading
The Village Global podcast takes you inside the world of venture capital and technology, featuring enlightening interviews with entrepreneurs, investors and tech industry leaders. Learn more at www.villageglobal.vc.
…
continue reading
Wharton faculty and industry leaders discuss their latest research, books, and relevant business topics. Hosted on Acast. See acast.com/privacy for more information.
…
continue reading
Custom Manufacturing Industry podcast is an entrepreneurship and motivational podcast on all platforms, hosted by Aaron Clippinger. Being CEO of multiple companies including the signage industry and the software industry, Aaron has over 20 years of consulting and business management. His software has grown internationally and with over a billion dollars annually going through the software. Using his Accounting degree, Aaron will be talking about his organizational ways to get things done. Hi ...
…
continue reading
In each episode of "Goldman Sachs Exchanges," people from the firm share their insights on developments shaping industries, markets and the global economy.
…
continue reading
Montgomery & Co. is a weekly podcast where WNBA champion and part-owner of the Atlanta Dream Renee Montgomery is joined by her mother Bertela Montgomery, her sister Nicole Young and her wife Sirena Grace as they chart a unique path through the business world as four black and brown women keeping their family first at all times. Both insightful and compelling, this one-of-a-kind talk show combines interviews with some of the world’s top innovators & entrepreneurs with sports and culture conve ...
…
continue reading
Each weekday, Marketplace’s Kai Ryssdal and Kimberly Adams make today make sense. Along with our supersmart listeners, we break down happenings in tech, the economy and culture. Every Tuesday we bring on a guest to dive deeper into one important topic. Because none of us is as smart as all of us.
…
continue reading
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