The Online-Seminar will take place in 11 months, on 03-12-2024 from 09:00 – 12:00 .

PRRC “person responsible for regulatory compliance” I

The PRRC “person responsible for regulatory compliance” (PRRC – Article 15, MDR) has multiple new tasks and duties within the current medical device regulations in Europe: Ensuring the conformity of the medical devices supplied, from development and through production and quality control, to release on the market. In Part I of II Mr. Stok will illustrate these requirements and will focus upon a practical understanding of the pre-market tasks (MDR Art. 15-3 a and 3b) and responsibilities resulting from the MDR and its MDCG guidelines as well as the associated implementation within the company QM system.

Target group and previous knowledge

The seminar is aimed at employees of medical device manufacturers from risk class I. We do not recommend any specific prior knowledge, but the following prior knowledge is advantageous:

  • Role and Activity at a medical device manufacturer or EC-REP
  • Experience as a QM- or RA-representative or Tech Doc Manager
  • (Internal) auditor or consultant for medical device manufacturers or EC-REP

Contents

Regulatory Requirements for the responsible person
Contents of the technical documentation
The conformity assessment procedure
Tasks and integration in the QM system

Discounts

Customer discount: mdc customers receive a 10% discount on the net price.

 

Notes

Please note that the registration fee and the associated participation only applies to one person. If several people take part in the seminar (remotely) even though only one person has registered, we reserve the right to exclude them from the seminar.

Price per participant

450.00 Euro (plus value added tax)