introduction

The seminar on "Post-Market Surveillance under MDR" helps Regulatory Affairs Managers/Quality Managers to learn how to create product-specific, realistic and MDR-compliant PMS plans.

With their first PMS plan created in the seminar and the skills they have acquired, they will pass the audit in the future and establish safe and efficient products on the market. In addition to the seminar documents, you will receive our templates for the PMS plan, which have already been tried and tested in many audits, as well as the procedural instructions for the PMS process.

(Teaching) goals of the seminar

The participants learn which requirements they have to meet by the MDR and the relevant MDCG documents in relation to post-market surveillance. You will also learn how other standards, in particular ISO TR 20416, can help with practical implementation. At the end of the seminar, the participants have created their first complete PMS plan, which is both product-specific and realistically implementable as well as legally compliant and will therefore pass the audit.

As a participant, you learn

  • Know the definition and classification of the PMS process in the overall process of technical documentation
  • Know the regulatory bases for PMS plans
  • Know the required elements of a PMS plan
  • how you can select possible data sources of the PMS and plan their evaluation
  • how to create a product-specific PMS plan
  • How to review a PMS plan for meaningfulness, completeness, and compliance

This will enable participants to leverage post-market surveillance for their business by:

  • avoid regulatory problems during audits,
  • communicate with auditors and examiners on an equal footing,
  • Minimize problems with the approval of the products and
  • Reduce effort and costs in the legally compliant implementation of post-market surveillance

KONTAKT:
Frankfurt

 

Mehr Informationen