Let's Talk Risk!
Let's Talk Risk! with Dr. Naveen Agarwal
RM roundup #3: 10 noteworthy risk-related LinkedIn posts
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RM roundup #3: 10 noteworthy risk-related LinkedIn posts

A reading of highlights from 10 noteworthy risk-related posts recently published on LinkedIn. Links to each original post and their authors are listed in notes below.

Listen to my reading of a recent LinkedIn article I published to cover 10 noteworthy risk-related posts recently published on LinkedIn. Listen to the recording and follow links below to read the original posts and continue the conversation.


🗞️A roundup of 10 noteworthy risk-related posts on LinkedIn!


1️⃣ Horst Simon advises risk practitioners to serve as advisors and facilitators instead of playing a traffic cop.


2️⃣ Jijo James shares a new tool that significantly reduces device-related interruptions when used with the WHO's surgical safety checklist.


3️⃣ Aaron Joseph recommends adopting a more flexible "re-entrant design controls" approach to manage frequent design changes and upgrades.


4️⃣ Stefan Hunziker, PhD, CICP offers 6 tips for boosting your risk management expertise where leaning from failures is not an option.


5️⃣ Wag Hanna shares how augmented intelligence tools can help support risk management while also enabling a culture of transparency.


6️⃣ Vincent F. Cafiso seeks to clarify FDA's position on requirements for clinical studies in QMSR.


7️⃣ George Zack invites a conversation to identify risks in real world activities such clearing snow from sidewalks and roads.


8️⃣ Chuck Ventura offers tips for considering design controls at the drug/device interface in a combination product.


9️⃣ Daniel Adler spotlights a new FDA draft guidance on cybersecurity to cover any device if it includes software and internet connectivity.


🔟Marco Felsberger reminds us that we can't always reliably model extreme events and managing risk exposure might be more effective.


Share in comments 👇your favorite risk-related post covered in this podcast.

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Let's Talk Risk!
Let's Talk Risk! with Dr. Naveen Agarwal
Every Friday, Dr. Naveen Agarwal leads a Let's Talk Risk! conversation with industry colleagues to discuss practical challenges and share best practices in risk management. In the highly regulated world of medical devices, most practitioners struggle with the "how" of risk management. Regulatory requirements are complex, confusing and ever changing. Establishing an effective risk management process that satisfies the scrutiny of regulators and auditors without creating barriers to innovation is a significant challenge in the industry. Dr. Agarwal believes that no single "expert" has all the answers, and it is only when we connect, share and learn from each other that we all become better. Let us keep learning together!