EU Postmarket Surveillance Requirements for Medical Devices скачать в хорошем качестве

EU Postmarket Surveillance Requirements for Medical Devices

When the EU MDR was released, every company with a CE Marked device suddenly had to update their Technical File procedure and Postmarket Surveillance procedure. Everyone was overwhelmed by the work required to conduct postmarket surveillance and postmarket clinical follow-up (PMCF). To reduce the labor required for postmarket surveillance, software companies have created new products that automatically download adverse event and incident reporting data from various websites. On February 9th, we hosted a live webinar reviewing the EU requirements for PMS in the morning. Suppose you are looking for links to the adverse event databases for European countries and other countries outside of Europe. In that case, this information is included in our post-market surveillance procedure (SYS-019) that is for sale: https://medicaldeviceacademy.com/post... - See Appendix A for links to European Databases for Adverse Event Reporting In the afternoon of the 9th, we are hosting a second PMS webinar about US FDA requirements for PMS. We will also go into depth about how to conduct automated searches for PMS data using a software tool. Timestamps 0:00 Intro 1:33 ISO 13485:2016, Clause 8.2.1 2:53 AAMI/ISO DTIR 20416:2020 - Medical Devices - Post-market surveillance for manufacturers 3:59 PMCF & Clinical Evaluations 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 Survey 31:35 PMS vs. PMCF 39:46 PMS & PMCF Address Residual Risks 41:09 What is the purpose of PMCF? 44:46 Methods & Procedures for PMCF 45:01 What needs to 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 (Question about Legacy Devices) 56:37 PSUR Web Form - Annex V of MDCG 2022-21 57:40 How do you write PMS documents? 1:01:00 Article 108, Device Registers & Databanks 1:02:31 Contact Us - Reminder for US FDA PMS Requirements 1:03:20 Basil Systems software tool for PMS searches 1:04:13 Basil Systems Postmarket Surveillance Dashboard 1:07:15 Question - What rationale can be used to avoid PMCF studies? (see MEDDEV 2/12-2 rev 2 - page 9 - 17 reason you may need to conduct 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 enough to meet the requirement for proactive PMS? 1:20:01 Question - Can you group devices with the same formulation if they have different classifications or Notified Bodies? 1:22:40 - Conclusion & Thankyou Link to related afternoon webinar on US PMS Requirements -    • US Postmarket Surveillance Requiremen...