Presented by
Management Forum
This one day course will cover the role of the Person Responsible for Regulatory Compliance (PRRC) introduced by the implementation of the Medical Device Regulation 2017/745 and the In-Vitro Diagnostic Device Regulation 2017/746. The course will review Article 15 from the regulation in detail to enable understanding of the intent of each requirement. It will also present the UK Medical Device Regulation requirements and discuss the proposed Qualified Person role with current information.
19 September 2023
from £549
This one day course will focus on the role of the Person Responsible for Regulatory Compliance (PRRC) introduced by the implementation of the Medical Device Regulation 2017/745 and the In-Vitro Diagnostic Device Regulation 2017/746. The course will review Article 15 from the regulation in detail to enable an understanding of the intent of each requirement. It will also present the UK Medical Device Regulation requirements and discuss the proposed Qualified Person role with current information.
Integration of the PRRC role into the Quality Management System will be discussed with real-world examples used throughout the day. In addition, the provision of the service by third parties will be investigated including how to support all requirements whilst being remote from the manufacturer. A case study looking at who should be a PRRC and a final scored assessment will also be included.
This is an excellent opportunity to understand the importance of the PRRC role and its place in your organisation.
This course is part of our Regulatory Affairs Training course collection, which features updates on the latest regulations to registration procedures and strategies.
NEW higher discounts for multiple bookings - bring your colleagues to make your training budget go further:
Please contact us for pricing if you are interested in booking 5 or more delegates
19 September 2023
Live online
09:00-16:45 UK (London) (UTC+01)
10:00-17:45 Paris (UTC+02)
04:00-11:45 New York (UTC-04)
Course code 14165
Until 15 Aug
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* Early booking discounts may not be combined with other discounts or offers. As such, the discounts for 2nd/3rd/4th delegates are based on the full price.
Multiple colleagues? See above for details of our discounts for 2, 3, or 4 delegates. For more, talk to one of our training experts to discuss how to: