34:00
LTR 66: Understanding human factors aspect of augmented reality applications in medical devices
35:15
LTR 65: Demystifying risk-based approach vs. risk management
01:25
LTR 64: Opportunities and challenges to leverage PCCP for speed to market
35:51
LTR 63: A lawyer's perspective on the QMSR transition
30:49
LTR 62: Overcoming barriers to cross-functional communication and collaboration
39:24
LTR 61: Treat human factors as a driver of customer satisfaction, not a check-the-box activity
06:35
Medical Device Software Risk Management - Challenges and Tips
31:08
LTR 60: Defining state of the art can be challenging; here are a few tips.
32:14
LTR 59: FDA's pre-sub program and how it can accelerate medical device innovation
41:23
LTR 58: Tips for clinicians transitioning into a medical safety role in MedTech
02:39
Understanding terminology - SaMD, AI, ML
34:09
LTR 57: It's time to focus on supply chain resiliency not just supplier management
31:28
LTR 56: How to communicate effectively with senior management
02:16
Webinar: How to set up post-market surveillance for your medical device
33:18
LTR 54: Start your risk analysis by first defining the intended use
35:41
LTR 53: Three big trends to watch in MedTech
34:20
LTR 52: The key to success as a risk practitioner in the medical device industry.
01:36
Collaborate for success in risk management
35:17
LTR 50: Humility is the key to startup success
21:51
RM roundup #3: 10 noteworthy risk-related LinkedIn posts
06:53
Webinar: FDA warning letter case study
34:42
LTR 49: A clinician's view on AI/ML enabled medical devices
34:39
LTR 48: Integrating purchasing controls across product lifecycle
11:21
Webinar: How to create a master harms list using standard codes
33:22
LTR 46: Tips to boost effectiveness of medical device post-market surveillance
02:56
LTR Weekly Digest #31 - 6th April, 2024
31:23
LTR 45: A patient's perspective on CGMs
34:18
LTR 44: Why we need a new approach to learning medical software and medical AI
20:43
RM roundup #2: 10 noteworthy risk-related LinkedIn posts
38:15
LTR 43: Tips for integrating risk analysis with design controls
08:03
Webinar: Benefit-risk evaluation of an AI/ML enabled medical device
20:59
RM roundup #1: 10 of my favorite risk-related LinkedIn posts
02:19
State or event? A new way to think about the term Hazard.
33:55
LTR 42: State or event? Thinking clearly about hazards will help you manage risk.
42:02
LTR 40: A guest podcast with NAMSA - Part 1
02:12
How to create reliability targets using a risk-based approach
33:20
LTR 39: Overcoming challenges in linking risk management with design controls
01:53
Barriers to collaboration in risk management
34:59
LTR 38: How medical safety professionals can serve as culture brokers in MedTech
02:15
Why QMSR, why now?
08:18
Webinar: Getting Ready for QMSR
33:39
LTR 36: Why we should not overlook the quality-of-life benefit in risk evaluation
01:55
Why QA/RA professionals should embrace AI for career growth.
03:26
LTR Weekly Digest #19 - 13th January, 2024
34:29
LTR 35: Tips for improving collaboration in risk management
03:24
LTR Weekly Digest #18 - 6th January, 2024
32:45
LTR 34: Build a culture of Quality to achieve inspection-readiness at all times
06:35
Webinar: Why FMEA alone is not sufficient for risk analysis
38:01
LTR 33: AI and the future of work for QA/RA professionals
02:09
Use a risk-based approach to design connected medical devices
35:20
LTR 32: A new paradigm for building connected medical devices
33:37
LTR 31: Focus on the purpose to measure process effectiveness
01:40
There is more to risk analysis than FMEA
01:13
Simplify risk management to support innovation in diagnostic devices
35:05
LTR 30: It is time to unfake risk management!
02:06
Understand the difference between AI and ML
01:28
Build empathy to motivate and empower your team
01:47
Understand the link between clinical evaluation and state-of-the-art
02:15
Benefits of early clinical input in medical device design
01:20
Communicating regulatory risk in business terms
X
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.
Tags