Let's Talk Risk!
Dear colleagues, hello 👋If you are looking for practical tips and insights about medical device risk management, you have come to the right place!
My name is Naveen Agarwal. My mission is to elevate our collective capability in risk management across the global medical device industry so we can significantly improve patient safety, accelerate innovation and reduce cost.
Let us face it - risk management is now much harder than before in the rapidly changing global regulatory environment. Medical device regulation in the EU, for example, includes references to risk management more than 250 times! The US FDA is also working on harmonizing the Quality System Regulation (QSR) with ISO 13485:2016, which has a much higher emphasis on risk management.
In practice, risk management is difficult. That is why I am creating these videos with practical tips and insights. You can also subscribe to my free newsletter at naveenagarwalphd.substack.com/ for additional resources.
- 38:10
- 14 күн бұрын
LTR 67: 3 pillars for defining your IVD risk management strategy
- 34:00
- 21 күн бұрын
LTR 66: Understanding human factors aspect of augmented reality applications in medical devices
- 35:15
- 28 күн бұрын
LTR 65: Demystifying risk-based approach vs. risk management
- 39:24
- Ай бұрын
LTR 61: Treat human factors as a driver of customer satisfaction, not a check-the-box activity
- 2:39
- 2 ай бұрын
Understanding terminology - SaMD, AI, ML
- 35:41
- 3 ай бұрын
LTR 53: Three big trends to watch in MedTech
- 1:36
- 4 ай бұрын
Collaborate for success in risk management
- 35:17
- 4 ай бұрын
LTR 50: Humility is the key to startup success
- 21:51
- 4 ай бұрын
RM roundup #3: 10 noteworthy risk-related LinkedIn posts
- 6:53
- 4 ай бұрын
Webinar: FDA warning letter case study
- 34:42
- 5 ай бұрын
LTR 49: A clinician's view on AI/ML enabled medical devices
- 2:56
- 5 ай бұрын
LTR Weekly Digest #31 - 6th April, 2024
- 31:23
- 5 ай бұрын
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