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On February 9, we hosted a live webinar in the morning discussing EU requirements for PMS.
Suppose you are looking for links to the side effect databases for European countries and other countries outside Europe. In that case, this information is included in our post-market surveillance procedure (SYS-019) available for purchase:
https://medicaldeviceacademy.com/post-market-surveillance-procedureform/ – See Appendix A for links to European adverse event reporting databases
On the afternoon of the 9th we will be hosting a second PMS webinar on the US FDA requirements for PMS. We'll also delve into how to perform an automated search for PMS data using a software tool.
Timestamps
0:00 Introduction
1:33 ISO 13485:2016, clause 8.2.1
2:53 AAMI/ISO DTIR 20416:2020 – Medical devices – Post-market surveillance for manufacturers
15:59 PMCF and clinical assessments
8:20 Additional resources
10:50 Post-market surveillance loop
18:52 Regulation 2017/745 Annex XIV Part A & B
19:20 Basic information to include in your PMS survey
26:00 Examples of PMS research
31:35 PMS vs PMCF
39:46 PMS and PMCF address remaining risks
41:09 What is the purpose of PMCF?
44:46 Methods and procedures for PMCF
45:01 What should be in your PMCF plan?
45:54 Additional PMCF requirements
46:06 PMS plan content requirements
50:16 Article 86 – PSUR
51:00 Article 86 continued
51:27 PSUR decision tree from MDCG 2022-21 (Figure 2)
52:24 PSUR content requirements (legacy device question)
56:37 PSUR Web Form – Appendix V of MDCG 2022-21
57:40 How do you write PMS documents?
1:01:00 Article 108, Device registries and databases
1:02:31 Contact Us – US FDA PMS Requirements Reminder
1:03:20 Basil Systems software tool for PMS queries
1:04:13 Basil Systems Postmarket Surveillance Dashboard
1:07:15 Question – What reason can be used to avoid PMCF examinations? (see MEDDEV 2/12-2 rev 2 – pages 9 – 17 why you may need to perform a PMCF)
1:12:52 Question – Is there a universally accepted function for the acceptability of PMS trend data?
1:17:04 Question – Is checking literature and databases sufficient to meet the requirement of proactive PMS?
1:20:01 Question – Can you group devices with the same wording if they have different classifications or notified bodies?
1:22:40 – Conclusion and thanks
Link to a related afternoon webinar on US PMS requirements – https://youtu.be/tOMIjUNyGGg
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