Person Responsible for Regulatory Compliance (PRRC) Seminars (MDR/IVDR)

During October & November 2021, we will run 2 Seminars on the Person Responsible for Regulatory Compliance (PRRC);
Both seminars will be delivered in English with a live Q&A session at the end of each Seminar (presentations are pre-recorded).

- Beginners seminar: 19-20 October, 2021
- Advanced seminar: 2-3 November, 2021

PRRC seminar is fully booked - registration is closed

We will announce new dates for our next seminar soon.

We welcome you to register the waiting list for our next seminar and receive an email for early bird registration in special price!

Thanks for register!

Beginner Seminar

Two-day of comprehensive seminar which aims to provide initial knowledge and concepts for those interested in understanding and performing the role of Person Responsible for Regulatory Compliance (PRRC).

The seminar is delivered by top industry experts who will review the regulation of medical devices in Europe (MDR/IVDR).
 

Seminar Topics:

  • Review of the new regulations of the European Medical Equipment Regulation (MDR / IVDR)

  • The role and duties of a PRRC.

  • Qualifications and experience of the PRRC

  • CE marking

  • Quality management system

  • Risk management and notified bodies

Who is this seminar for?

  • Medical equipment manufacturers

  • The team responsible for the regulation in the organization

  • RA manager, RA director, QA manager, QA director

Day 1

Day 2

Register now for PRRC beginner Seminar

 18.9.21 Special price for early registration - Before *

Two-day seminar delivered as a follow-up to the beginner seminar and aimed at preparing the participates for the role of Person Responsible for Regulatory Compliance (PRRC) in their organization!

What does the online seminar provide?

Preparing you for the position of PRRC in your organization

  • In-depth knowledge of the requirements for MDR and IVDR.

  • How to properly check the conformity of the devices.

  • Establish verification which is proportionate to the risk class and the type of device

  • Maintain the technical documentation and the EU declaration of conformity.

  • Adapting the organization to the European market everyday changes. 

 

Who is this seminar for?

  • Medical equipment manufacturers

  • The team responsible for the regulation in the organization

  • RA manager, RA director, QA manager, QA director

 Advanced Seminar

Day 1

Register now for PRRC advanced Seminar

Day 2

  18.9.21 Special price for early registration - Before *

Speakers

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Janette Benaddi

Consultant | Obelis Group

Business mentor, international speaker/trainer and expert consultant to the medical device industry.  Janette has over 25 years’ experience of managing pre and post market clinical studies in both devices and pharmaceuticals.

Business mentor, international speaker/trainer and expert consultant to the medical device industry.  Janette has over 25 years’ experience of managing pre and post market clinical studies in both devices and pharmaceuticals.

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Helene Quie

CEO Qmed Consulting | Obelis Group

Co-founder of Qmed Academy and senior advisor. Helene has 25 years of experience in the medical device industry, supporting companies from start-up to well established companies.

Co-founder of Qmed Academy and senior advisor. Helene has 25 years of experience in the medical device industry, supporting companies from start-up to well established companies.

Co-founder of Qmed Academy and senior advisor. Helene has 25 years of experience in the medical device industry, supporting companies from start-up to well established companies.

Co-founder of Qmed Academy and senior advisor. Helene has 25 years of experience in the medical device industry, supporting companies from start-up to well established companies.

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CEO and co-owner of QUNIQUE GmbH, a medical device and in-vitro diagnostic consultancy company, located in Germany and Switzerland. He spent the last decade as a subject matter expert at the biggest notified body in Europe and represented locally and the globally the notified body association in the various European discussion. 

Sandra Ferratti

Chief Compliance Officer | Obelis Group

Chief Compliance Officer at Obelis, the leading EU player in cosmetics regulatory consulting and Responsible Person services.  More than 20 years of experience in EU regulatory affairs with expertise in Cosmetics. Specialized in the profession of Responsible Person and Person Responsible for Regulatory Compliance.

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Anne Jury

Vice President of Team PRRC

Has over 18 years’ experience in the medical and diagnostic healthcare products industries. Specialties: Technical guidance on regulatory strategies for new medical device product commercialization, including CE marking requirements, implementation of management systems to ISO 13485:2016 and training / coaching in these areas.

Regulatory affairs consultant with over 18 years’ experience in the medical and diagnostic healthcare products industries. Specialties: Technical guidance on regulatory strategies for new medical device product commercialization, including CE marking requirements, implementation of management systems to ISO 13485:2016 and training / coaching in these areas.

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Louise Olliver

Regulatory expert | Obelis Group

Has more than 30 years’ experience in regulatory affairs and quality management in the fields of medical devices, in vitro diagnostics and pharmaceuticals. Her consultancy business was established in 1989 and has been engaged by a broad range of clients from small-scale start-up companies, consultancies, to blue-chip corporations.

Has more than 30 years’ experience in regulatory affairs and quality management in the fields of medical devices, in vitro diagnostics and pharmaceuticals. Her consultancy business was established in 1989 and has been engaged by a broad range of clients from small-scale start-up companies, consultancies, to blue-chip corporations.

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John L. Webster

Senior Regulatory Consultant Obelis Group

Has over 40 years of quality assurance, regulatory and management experience and served for many years as European Director of Regulatory Affairs for Boston Scientific based in Paris and previously for Meadox Medicals Inc. in UK.

Senior Regulatory Consultant Obelis Group

Has over 40 years of quality assurance, regulatory and management experience and served for many years as European Director of Regulatory Affairs for Boston Scientific based in Paris and previously for Meadox Medicals Inc. in UK.

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Roland Gerard

Manager | Regulatory Affairs Department

with 30 years of experience in the field of high risk implantable medical devices. During all those years, he has developed an in-depth knowledge of EU Medical Device Directives and Environment Legislation as well as standards and quality management system (ISO 13485) implementation and certification.

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Bassil Akra

CEO Qunique Gmb

The CEO and co-owner of QUNIQUE GmbH, a medical device and in-vitro diagnostic consultancy company, located in Germany and Switzerland. He spent the last decade as a subject matter expert at the biggest notified body in Europe and represented locally and the globally the notified body association in the various European discussion.