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Hungry to learn about ISO 14971 and QMSR?
Our friend Etienne Nichols and the good people over at Greenlight Guru hosted a wonderful discussion between Christie Johnson (Prodct) and Edwin Bills (Edwin Bills Consulting, also a member of the Prodct Advisory Board) to discuss risk, ISO 14971, and QMSR.
Our favorite comments in the chat? “Now I’m hungry!” because Christie kept talking about how “delicious” it is to read ISO/TR 24971:2020 (Guidance on the application of ISO 14971). Give it a listen. You’ll know what we mean.
FDA QMSR Through The Lens Of Risk Management
Edwin Bills, Christie Johnson, and Jayet Moon describe how the new QMSR was shaped by ISO13485:2016 while still retaining its core. They explore how risk management is a key focus, with an emphasis on integrating risk-forward thinking throughout the QMS.
Why risk practitioners must build empathy muscle
Risk management in medical devices is a strait-forward, cold, calculated process -- right? Nope. It requires ❤️ heart. It requires 💬 open communication. It requires 🙌 empathy.
Every Friday at 11:00 (ET) Naveen Agarwal, Ph.D. streams wonderful live "Let's Talk Risk!" conversations via LinkedIn Live. LTR! episode 21 features Christie Johnson as the guest talking about two of her favorite topics: risk management for medical device startups AND why empathy matters.
Give it a listen. We hope you find something useful in the conversation.
Intersection of ISO 13485 and ISO 14971 under FDA QMSR
The most popular guest column of 2023 for Med Device Online! Edwin Bills and Christie Johnson describe the intersections of ISO 13485:2016 medical devices quality systems standard and ISO 14971:2019 medical device risk management standard, which the FDA believes is key to the new QMSR.
Using Quality and Risk as Tools, not Hurdles
Do you come from a development background but are leaping into new waters with medical devices?
This podcast is recorded for you and provides a great overview of quality, product development processes, design controls, managing risk, and the importance of documentation in this unique industry.
Christie Johnson speaks with Grant Chapman and Ben Ettinger in episode 14 of the Glasslab Podcast and it’s full of great advice plus a few good laughs.
Project Management for Product Development of Medical Devices
What is the best way to approach project management (PM) for medical device product development? Don't settle for the trial and error method, turn to the experts with proven best practices for managing your product development project.
In this 233rd episode of the Global Medical Device Podcast, Jon Speer talks to Devon Campbell and Christie Johnson about the things they all love to hate about Project Management for Product Development of Medical Devices, the appropriate time and place for PM practices and tools, following the Keep It Simple Stupid (KISS) philosophy, and plenty of “hot garbage” situations. It’s a fun listen.
'Who, What, When' of Quality in the Medical Device Industry
There are many schools of thought when it comes to the 'who, what, and when' of quality management for medical devices. Who is responsible for quality? What does quality mean for me? When should I get started? These questions and many more are explored in episode 114 of the Global Medical Device Podcast where host Jon Speer and Christie Johnson offer their insights and guidance on medical device quality management best practices.
Building Startup Quality Culture
Season 1, Episode 30 of Quailo’s From Lab to Launch Podcast features Devon, Christie, and several other industry experts who work closely with medical device entrepreneurs and startups discussing tips related to fostering a culture of quality in medical device startups. They dive deep into the essential strategies for building a transparent, mistake-embracing environment. Learn how leveraging data-driven decisions can significantly impact the quality of your medical device, the importance of documenting every step for success, and the power of preventive actions. This conversation is a treasure trove for any early-stage medical device company aiming for excellence in quality.
Why is this important?
For starters, early stage companies enjoy a unique opportunity to create the culture they want internally right from the start!
However, if you’re financially motivated, consider the following future should your startup eventually grow into a mature company…
“A company with a highly developed culture of quality spends, on average, $350 million less annually fixing mistakes than a company with a poorly developed one.”
- Harvard Business Review article “Creating a Culture of Quality” by Ashwin Srinivasan and Bryan Kurey