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Webinar 10: Tips for medical device software risk analysis
An overview of key challenges and tips for analyzing the risks of medical device software failures.
 • 
Naveen Agarwal, Ph.D.
1
48:31
Webinar 9: How to set up post-market surveillance
A review of ISO 14971 requirements and practical tips to set up an efficient and effective post-market safety surveillance process for your medical…
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Naveen Agarwal, Ph.D.
54:26
Webinar 8: Case study discussion and Q&A
Watch now | A case study about a warning letter for miscalculating risk and a general Q&A session about risk management.
 • 
Naveen Agarwal, Ph.D.
56:41
Webinar 7: How to create a master harms list using standard codes
A step by step method to help you create a master harms list using FDA, IMDRF or MedDRA codes.
 • 
Naveen Agarwal, Ph.D.
1
56:50
Webinar 6: Benefit-risk evaluation of an AI/ML enabled device
Watch now | A step by step process to conduct a benefit-risk evaluation of an AI/ML enabled medical device using FDA guidance.
 • 
Naveen Agarwal, Ph.D.
55:27
Webinar 4: Why FMEA alone is not sufficient for risk analysis
FMEA is a useful technique for analyzing potential failure modes, but it is not sufficient by itself to satisfy the requirements of risk analysis…
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Naveen Agarwal, Ph.D.
Webinar 3: A practical approach for analyzing benefit-risk of medical devices
In this month's webinar, we discuss 2 ways you can use evaluate the overall benefit-risk of your medical device and illustrate a holistic approach based…
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Naveen Agarwal, Ph.D.
Webinar 2: two ways to estimate the probability of harm
In this month's webinar, we discuss 2 ways you can use the post-market surveillance data to estimate the probability of harm, and how it can help you…
 • 
Naveen Agarwal, Ph.D.
Webinar 1: 7 essential elements of a risk management plan
LTR monthly webinar takes you deeper into ISO 14971 requirements for a risk management plan
 • 
Naveen Agarwal, Ph.D.
1
Webinar 1: 7 essential elements of a risk management plan
LTR's monthly webinar series kicks off with a deep dive into risk management plans
 • 
Naveen Agarwal, Ph.D.
Free webinar: Top management responsibility for risk management
A free sample of a benefit available to paid subscribers
 • 
Naveen Agarwal, Ph.D.
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