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Quick Tip: Promote a culture of collaboration with these tips
Risk management is a team sport. No one person has all the answers. Here are a few tips to help nurture a culture of collaboration for success in risk…
LTR 80: Building safety by design into medical devices
Insights from an open conversation with Alex Saegert.
34:01
Medical Device News Update - November 2024
FDA approvals, warning letters and Class I recalls issued during November 2024
 • 
Naveen Agarwal, Ph.D.
Quick Tip: PCCP is a great tool, but apply it strategically
Predetermined Change Control Plan (PCCP) is a great tool to accelerate innovation, but you need a strategy to apply it effectively in managing your…
LTR 79: Tips for SaMD development and success with FDA
Insights from an open conversation with J. David Giese.
31:31
Navigating Tricky Conversations with Senior Executives
In this guest post, Lesley Worthington offers 5 tips for getting your highly technical message across when communicating with senior executives.
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Lesley Worthington
Quick Tip: Improve your CAPA problem statement with GenAI
GenAI offers a unique opportunity to upgrade your QMS processes, including CAPA, for consistency, compliance and effectiveness.
LTR 78: New challenges in managing risks of software in IVDs
Insights from an open conversation with Megan Kane.
30:38
PCCP: Opportunity for risk practitioners to shine
FDA's PCCP guidance and recent approvals offer insights for risk practitioners to play a key role in accelerating development and growth of AI/ML…
 • 
Naveen Agarwal, Ph.D.
22:08
Quick Tip: Start getting ready for QMSR compliance before it is too late.
QMSR goes into effect in February 2026. FDA might apply some discretion but compliance will be expected the minute after it goes into effect. Develop a…
LTR 77: How GenAI is transforming Quality in MedTech
Deep insights from a conversation with Garth Conrad.
 • 
Naveen Agarwal, Ph.D.
29:55
EU vs. FDA: Aligned but different in their approach to safety of AI/ML devices
A new questionnaire from Team-NB, a recent FDA white paper and good machine learning practices offer a unique perspective on emerging regulatory…
 • 
Naveen Agarwal, Ph.D.
18:33
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