How to do Post-Marketing Surveillance in the US (vs EU)?
We talk a lot about Post Marketing Surveillance in Europe with EU MDR, MDCG, and all the rules to follow. But when you hear about how this is done in the US you will see that this is really completely different.
For that, I have invited Robert Packard to help us understand the rules behind it and also talk about an IT application that can help you to gather data for your PMS. Let’s review that together.
Who is Robert Packard?
I have 20 years of experience in the medical device industry and another 10 years of experience in biotech manufacturing validation and scale-up. I am a UConn graduate in Chemical Engineering. I was Director of Quality and Regulatory Affairs at four different medical device start-ups, and I was President/CEO of a laparoscopic imaging company I co-founded in 2004. My quality management system expertise covers all aspects of developing, training, implementing, and maintaining ISO 13485 and ISO 14971 certifications. From 2009-2012, I was a lead auditor and instructor for BSI – one of the largest Notified Bodies for CE Marking and MDSAP Certification.
Who is Monir El Azzouzi?
Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs.
Links from the Video
- 522 Post-Market Surveillance Studies Database: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pss.cfm
- Post-Approval Studies (PAS) Database: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pss.cfm
- Post Market Management of Cybersecurity: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/postmarket-management-cybersecurity-medical-devices
- MAUDE Database: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/search.CFM
- Basil Systems PMS Database Tool: https://basilsystems.com/easy-medical-device/
- Webinar on PMS EU and US: https://medicaldeviceacademy.com/post-market-surveillance-webinar/