How to become a PRRC with TEAM-PRRC (EU MDR & IVDR)
The PRRC is a new role within the EU MDR 2017/745. All medical device companies need a person within their organization to be responsible for that. In this episode, I have invited Team-PRRC which is a non-profit association that is representing the PRRC roles. They are here with me to explain more about it and also explain what are some of the difficulties. Within this session, Elem Ayne (President of Team-PRRC) and Anne Jury (Vice-President of Team-PRRC) accepted to answer my questions and will also share with you what Team-PRRC can do for you.
In this episode, Elem and Ayne will also mention the fees to be part of the association. They have a special offer until May 26th, 2021 which is the date of application of EU MDR.
Who is Elem Ayne?
Elem AYNE is a Quality & Regulatory Affairs Consultant and a member of “DM Experts” network (in France).
She has 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 herself in Regulatory affairs working especially in Class I reusable granted by 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 Anne Jury?
Anne Jury is a consultant in medical device regulatory affairs and quality management systems in the business she founded in 2000.
Before that, she was a lead auditor and area manager working for notified bodies, BSI and then TUV Sud, covering manufacturers large and small in Europe and North America for seven years. Her early career started out with a large medical device technology manufacturer where she was company microbiologist responsible for the release of all sterile devices in the days before CE marking even existed for medical devices.
In her current role, she works mostly with small start-up companies getting new quality systems implemented and developing the regulatory strategy for gaining market access for innovative new devices.
It is in this role that she has realised the potential challenges to be faced by the PRRC in micro and small enterprises and therefore happily accepted the invitation to become the Vice-president of Team-PRRC.
Who is Monir El Azzouzi?
Monir El Azzouzi is a Medical Device Expert specialized in Quality and Regulatory Affairs. After working for many years with big Healthcare companies and particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world.
Now, he has created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, Podcast, Online courses…
Links
- Elem Ayne LinkedIn profile: https://www.linkedin.com/in/elemayne/
- Anne Jury LinkedIn profile: https://www.linkedin.com/in/anne-jury-1967546/
- Team-PRRC website: https://www.team-prrc.eu/
- Podcast Episode 36: How to choose your PRRC with Erik Vollebregt: https://podcast.easymedicaldevice.com/36/
- Blog Post PRRC: https://easymedicaldevice.com/prrc/
2 Replies to “How to become a PRRC with TEAM-PRRC (EU MDR & IVDR)”
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Can the Management Representative of the company be a PRRC, if he/she has the qualification required to function as a PRRC?
Yes, any employee of the company that has the qualification and skills can be PRRC. I think that the management rep will be the most chosen person within medical device companies