03:44
Build equity in medical device design controls
31:41
LTR 29: Challenges and opportunities for digital technologies in medical applications
36:54
LTR 28: It is time to build equity in medical device design control
08:32
A practical approach for analyzing benefit-risk of medical devices
34:06
LTR 27: Practicable or not, that's the question for risk control
35:50
LTR 26: Seek clinical input early in development to achieve market success later
35:38
LTR 25: Career tip - learn to effectively communicate regulatory risk in business terms
07:06
Webinar: 2 ways to estimate the probability of harm
34:16
LTR 24: Clinical evaluation is a lifecycle process, not a one-time activity
32:06
LTR 23: Focus on intended use in the clinical environment for risk management of IVDs
33:43
Ep 22: Think of post-market surveillance as a value adding business process
06:35
Webinar: 7 Essential Elements of a Risk Management Plan
30:47
Ep 21: Why risk practitioners must build the empathy muscle
31:38
Ep 20: Team diversity helps boost competence in risk management
34:36
Ep 19: How QA/RA professionals can help drive innovation in AI/ML
34:48
Ep 18: Risk based approach to building a QMS in a startup
32:26
Ep 16: Clinical evaluation is now more important than ever under EU-MDR
09:39
Common mistakes in risk analysis
04:11
Quick tip - Be aware of the effect of risk perception
06:39
Expert Tp: Linking Hazards to Harms
06:53
Avoid this mistake in your risk analysis
58:00
Interactive Q&A, March 2022 - Let us talk about risk acceptability
01:00:23
Interactive Q&A Session - Apr 15, 2022
01:37
Purpose of the post-market surveillance process for medical devices
02:37
3 Steps to Ensure Data Quality for Post-Market Surveillance
32:46
Ep 15: Collaboration is the secret sauce for success in risk management
33:46
LTR14: The most important question for risk management: who is taking the risk?
41:01
Ep 13: Compliance: an obstacle or an opportunity?
36:02
LTR12: Risk lessons learned from working on a hydrogen-powered car
39:16
Ep 11: Understanding a physician's view on risk
43:04
LTR 10: Safety is important, but not the only objective for risk management
38:07
Ep 09: Tips for a risk-based approach to auditing Quality Systems
31:22
Ep 08: Understanding the interface between clinical evaluation and risk management
34:11
Ep 07: Risk management of IVDs requires a different approach
32:49
Best practices for using FMEAs for medical devices
27:13
Challenges in connecting risk management with design controls
25:38
Role of top management in risk management
27:04
Attributes of a good risk management report
29:49
Overall residual risk evaluation
28:29
Mistake to avoid in an FMEA
27:33
Risk analysis and evaluation in an FMEA
27:55
A framework for effectiveness of risk management
29:08
Understanding Sequence of Events and Hazardous Situations
41:36
Wisdom in Risk Management - A Conversation with Bijan Elahi
33:47
When FDA Disagrees with Your Risk Calculation Method
30:20
How perception influences benefit-risk
08:19
Live Training: ISO 14971:2019 Risk Management Requirements
29:58
Device-related interruptions during surgical procedures
38:27
Lessons from a recall - When one risk control introduces a new hazard.
28:57
Imagining a different world - What if risk management was not "required"?
31:04
Evolution of ISO 14971 - A Conversation with Ed Bills
23:22
Device Explants - A Challenging Situation for Risk Analysis
26:16
Listening to the Voice of the Patient
24:40
Lessons from a Warning Letter: Failing to Update Risk Matrix
07:55
QOTD - How effective is your risk management process?
58:34
Interactive Q&A Session - 21 January 2022
13:18
Digital Health Innovation: GI Genius - Helping Early Detection of Colorectal Cancer
09:45
What is Digital Health and Where it is Going?
08:04
Understanding Infection Induced "Natural" Immunity
46:35
Interactive Q&A December 2021 - FDA Warning Letter, EU-MDR Discussion
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About
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.
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