Can you go to Jail as a PRRC? [Elem Ayne]

We are starting to get more and more questions on the PRRC and I think this episode will help you a lot to understand what your responsibility is when you sign a contract as PRRC. In this episode, I will talk with Elem Ayne, President of Team-PRRC. We will look at the questions that this association is receiving. We will also discuss the first Team-PRRC conference and what will be talked about during that event. Join us if you are in the region.

Who is Elem Ayne?

Elem AYNE is a Quality & Regulatory Affairs Consultant and a member of the “DM Experts” network (in France). She started her career in R&D in microbiology, oncology, and biochemistry. She obtained 2 degrees in Business Development from 2 different Business Schools, then worked in several fields such as purchasing, supply chain, sales, marketing, quality, and regulatory affairs for different industries, in particular in sterilization. She has finally specialized in Regulatory affairs working especially in Class I reusable granted a Master’s degree in this field before founding her own company “ACR Medical” to support manufacturers in their compliance with MDR (EU) 2017/745. She is also the President of the Non-for-profit association Team-PRRC

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 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

Can a PRRC go to Jail with Elem Ayne from Team-PRRC and Monir El Azzouzi from Easy Medical Device

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