Understanding the requirements of regulation 2017/745/EU

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Objectives

  • Understanding the regulatory context for medical devices, its structure and scope of application
  • Understanding EU/2017/745 regulatory requirements

Audience concerned

Manufacturers/sub-contractors/distributors of MDs:
– Regulatory affairs/quality managers
– Staff with regulatory monitoring tasks
– Heads of Departments such as: Production, R&D, etc.
– Project managers, engineers

Aim

Acquiring the basics

Programme summary

  1. Introduction and objectives
  2. Historical context and applicable regulation
  3. Stakeholders and their role
  4. The principle of EC marking
  5. The EC marking technical report
  6. The Quality Management System – QMS
  7. Obligations of Post Market Surveillance – PMS
  8. Conclusion

Prerequisites

There is no prerequisite for this training.

Duration

1 day
7-hour classroom attendance

Inscription

Download the registration form

Date des formations CaduCeum Academy

Ref : CANRDM

Informations and registration : academy@caduceum.co.uk