Module 17 2024

27/11/2024

The Role of the RA Professional

Qualifications and experience:

“…the requisite expertise in the field of medical devices… demonstrated by…”

• Degree (or equivalent) in a relevant area

+ 1 year RA/QA experience in medical devices

OR

• 4 years RA/QA experience in medical devices

• 2 years experience for custom made devices

The Organisation for Professionals in Regulatory Affairs

Lecture 1

7

The Role of the RA Professional

Practical Issues:

• Available within the organisation

(Exemption for micro and small enterprises)

Duties can be shared

•

• Applies to manufacturers and Authorised Reps.

Registration on EUDAMED

•

• Guidance available: MDCG 2019-7 Rev 1

The Organisation for Professionals in Regulatory Affairs

Lecture 1

8

4