Requirements of the MDR for CE Marking Training Course - International

Niveau Exigences Durée 1 journée de formation

Disponible pour réserver: Salle de classe virtuelle 1130€ + TVA View dates and book now

This one-day medical device training outlines the key requirements, concepts and overall process for CE marking under the medical device regulation. It’s suitable for anyone working in regulatory affairs/quality assurance or staff partnering with medical device manufacturers.

This stage of your learning journey creates a solid base for implementing your own CE marking projects. It provides essential knowledge about EU medical devices and regulatory affairs from all areas of an organization. It also explains the demands that fall on subcontractors, importers and distributors.

After completing this medical device training, you will have a sound understanding of the medical device regulation and be able to communicate it to others. You will also gain eight CPD points and take away comprehensive training course notes.

Prerequisites

There are no formal prerequisites for this course.

Pedagogical objectives

The course will give you an understanding of the key requirements, which will provide:

Essential knowledge to understand Regulatory Affairs of Medical Devices
in EU, e.g. in the position of top management, or a manager or project
member in QM/QA, R&D, design, manufacturing, supply chain, customer service and sales
The ability to understand the demands of the subcontractor, supplier, OEM, authorized representative, importer, distributor, allowing better relationships between them and the legal manufacturer
A basis to learn later about implementation of CE-marking projects

- New starters in Regulatory Affairs (RA), personnel increasing their responsibility in this area, and RA professionals who are not familiar with the European MDR
- Personnel working with Regulatory Affairs departments, e.g. top management, manager or project member in QM/QA, R&D, design, manufacturing, supply chain, customer service and sales
- Staff working for organizations that partner with Medical Device manufacturers, e.g. as subcontractor, supplier, OEM, authorized representative, importer, distributor, auditee etc.
By the end of the course, delegates will be able to:
- Communicate the key requirements and concepts within the Regulation
- Reference the necessary aspects to evaluate if and how your company is affected by MDR and to what extent
- Define the vocabulary used within MDR
- Explain the structure and administration of the Regulation
- Recognize partners of manufacturers affected by the Regulation
- Describe key steps of a conformity assessment
- Explain the main impacts on the QMS relating to MDR
- Recognize requirements for postmarket surveillance and updates
- Course materials, provided electronically
- Letter of attestation
- Official certificate
Assessment specifics
- Questionnaire to assess the knowledge at the end of the training
- Customer survey
Course materials including:
- Introduction to the training, detailed program and security assignments
- Course presentation, theory and activities/role plays
- Answers to the activities
- Videos
- Additional documents, distributed during the sessions, to use for the activities
- Attendance sheet to be signedSkills
This guide will give you all the necessary information.
Download our training guide: Requirements of the MDR for CE Marking
* These training modules are eligible to the subsidizing by the public institutions in France (OPCO).

**Each delegate receives a training convention after enrollment.

***Please note that for the public sessions, you have until 48h before the start of the course to confirm your enrollment. For the in-house sessions, the deadline would be of two weeks prior to the start of the course.

****Should you be in a disabled situation, please contact us and indicate what details should be taken into account.

You can contact us on training.france@bsigroup.com or 01 89 79 00 40.

Nous contacter

Travaillons ensemble pour bâtir l'avenir de votre organisation

Contactez-nous pour découvrir comment nous pouvons vous aider à réussir

Nous contacter