In this episode, Claire Dyson will clarify to us what is the new PMS requirements from UK MHRA. You have maybe heard recently the UK MHRA saying that there should be a new requirement to perform Post-Marketing Surveillance for Medical Devices in the UK. So what this means? Who is impacted? How to comply? Listen to this episode.

Who is Claire Dyson?

Claire Dyson began her career in rational drug design and moved into medical device through devices that interact with drugs and drug-delivery systems. Claire entered certification bodies in 2018 and is now the Head of UK Approved Body for DQS, an international, accredited certification body offering ISO 13485, MDSAP and CE conformity assessment to medical device manufacturers. She is involved in DQS's application to become a UK Approved Body and offer UKCA conformity assessment. In parallel, she interacts with DQS's international team developing accessible content to support manufacturers with the regulatory pathways and transitions.

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

Claire Dyson LinkedIn:  Claire Dyson | LinkedIn 

Blogs – 3 part series on U vs UK PMS  

UK PMS Regulations: Overview & Key Requirements for Medical Device Safety 

UK Medical Device Vigilance – Part 2: Vigilance & Reporting Requirements 

UK PMS vs EU MDR – Key Differences & Impact on CE-Marked Medical Devices 

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi

Twitter: https://twitter.com/elazzouzim

Pinterest: https://www.pinterest.com/easymedicaldevice

Instagram: https://www.instagram.com/easymedicaldevice

Authorized Representative and Importer services:https://easymedicaldevice.com/authorised-representative-and-importer/