LTR Weekly Digest #14 - 2nd December 2023

Dear colleagues, hello! 👋

As we close on November 2023, I want to thank you for your continued support, and welcome the 100+ new colleagues who joined our community this month.

New tools on Substack now allow me to connect with you in a more direct and personal way! Please watch a brief video message above.

As an early Holiday gift, I would like to offer you a 14-day free trial so you can get full access to premium content on Let’s Talk Risk! Click below to take advantage of this limited-time special offer.

Upcoming events

LTR weekly conversation on LinkedIn: how collaboration between Medical Safety and Quality can help improve patient safety

Join me next Friday, December 08, 2023 at 11:00 AM EST, for another Let’s Talk Risk! conversation on LinkedIn. My guest next week is Mark Armstrong, who will discuss how close collaboration between Medical Safety and Quality can help improve patient safety. Click below to learn more and add it to your calendar!

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👇Here are links to articles published last month on Let’s Talk Risk!

Premium content

Case Study: When benefit-risk falls below expectations despite solid clinical data

Webinar 3: A practical approach for analyzing benefit-risk of medical devices

ISO 14971 Fundamentals: Reasonably Foreseeable Misuse

Medical Device News Update - October 2023

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Free content

1. Let’s Talk Risk! conversations

LTR 30: It is time to unfake risk management!

LTR 29: Challenges and opportunities for digital technologies in medical applications

LTR 28: It is time to build equity in medical device design control

LTR 27: Practicable or not, that's the question for risk control

2. Quick tips

Quick Tip: A hazard is more than just a potential source of harm

Quick Tip: Focus on quality system processes that most directly impact safety and effectiveness

Quick Tip: Use a patient-focused method when estimating risk

Quick Tip: Build a strong link between clinical evaluation and risk management

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