Introducing Exeed’s New Webinar Series: Sharing Knowledge, Solving Problems
Join Dr. Naveen Agarwal for a Discussion of ISO 14971 and Common Questions Surrounding It
Exeed is happy to introduce our new webinar series, Sharing Knowledge, Solving Problems, hosted by Dr. Naveen Agarwal. These interactive webinars are an opportunity for the medical device community to come together and discuss questions and obstacles surrounding ISO 14971 and risk management. The risk management industry presents many challenges, even for those who have been in the field for a long time. It is our hope that this webinar series provides a space for engaging with peers, collectively solving problems, and improving understanding.
Watch the Webinar
Below, you can find a recording of the first webinar session as well as timestamps for the questions asked.
Timestamps for Questions Asked:
05:56 - Strategies for demonstrating that benefits outweigh residual risks
07:36 - Questions from regulatory bodies to challenge benefit-risk
08:58 - Estimating risk of software failures
11:16 - Major benefits of using an FMEA vs Fault Tree analysis
12:24 - How do you demonstrate benefit-risk when the device has an indirect benefit (e.g. software)
17:25 - How often do you recommend updating FMEAs
17:23 - What is the difference between process and design FMEA
20:01 - Where is the best place to document the remaining risks
21:30 - Connectivity of the design and process relating to FMEAs
23:42 - Risk management documents and updates for regulatory changes such as EU-MDR
24:58 - What is a case where the severity of a hazard can change over time?
28:15 - How do you address hazards that may not be applicable in a process risk assessment?
32:58 - Does the US risk management approach mirror the EU MDR approach
34:40 - What is an easy way to gather data or information on aspects that could lead to a modification in the hazardous situation that can increase the severity? Are there some harms you should pay more attention to?
38:19 - Are risk management documents useful in 510k/PMA submissions?
39:49 - Based on pFMEA updates, must a PRA be completed if the overall risk profile does not increase to comply with ISO 14971?
41:18 - What are the standards risk management deliverables for medical devices?
42:56 - Do EU-MDR safety requirements go beyond ISO 14971?
44:57 - Can you explain benefit-risk assessments in more detail?
46:52 - Is there a requirement to have separate FMEAs for the process, design, etc from regulatory point of view?
48:47 - What is the relationship between sampling plan and risk level?
51:06 - How to measure residual risks, how to manage and monitor them over time? What type of documentation I should use?
We look forward to hosting further discussions and to continuing to share our knowledge. To register for future webinars, click here.