Implementation of MDR for CE Marking training course - International

Niveau Mise en œuvre Durée 3 journées de formation

Disponible pour réserver: Salle de classe virtuelle 2410€ + TVA View dates and book now

This three-day course from your partner in learning is especially useful for regulatory affairs, quality management and quality assurance professionals who need to implement the medical device regulation (MDR).

The MDR training is also designed for people working for organizations that partner with Medical Device manufacturers. You will learn all the requirements needed for conformity assessment, how to fulfill technical documents and how to plan post-market activities required by the MDR.

By the end of the course you will be able to put all this knowledge into working practice in your organization.

Prerequisites

You must have a good understanding of the requirements in the MDR, which is conveyed by our one-day Requirements training course or our MDD to MDR transition course.

You should also have either experience with, or basic knowledge, of quality management systems for the medical device industry, or good understanding of European Medical Device legislation, or some experience in pre or post-market
activities within the EU.

Pedagogical objectives

Implement the requirements of the European Medical Devices Regulation
Guide and support other people and partner organizations affected by MDR
Set up and update required documentation
Take the necessary steps for your organization to meet the MDR requirement
Maintain compliance to MDR and other/future documents related to Medical Device legislation
Systematically explore and implement more detailed and updated provisions (e.g. common specifications (CS), acts,standards)

- RA, QM, and QA professionals who need to implement the MDR
- Anyone concerned with certification or active in projects for CE-marking
- Staff working for organizations that partner with Medical Device
  manufacturers e.g. as subcontractor, crucial supplier, OEM, Authorized
  representative, importer, distributor, auditee
- Develop a strategy for regulatory compliance as stipulated by MDR
- Implement requirements concerning the following steps for Conformity
  Assessment
- Scope and applicability of MDR
- EU risk classification criteria for medical devices to determine “Risk
  Class”
- General Safety and Performance Requirements (GSPRs) as the basis for
  CE marking, including the use of standards
- Conformity assessment routes and their application based on risk class
- Self-certification, CE-certification by Notified bodies, involvement of
  authorities, scrutiny
- ‘Declaration of Conformity’ and CE marking
- Fulfil Technical Documentation requirements, e.g. in:
- Putting together ‘Technical Documentation’
- Necessary control of outsourced activities and processes and roles of
  external partners (e.g. supplying and commercial)
- Instantiate the importance and role of clinical data
- Risk management, process validation and their regulatory significance
- Drawing up Instruction For Use, label and other information supplied with the device
- Consistency and validity of information and electronic data
  management
- Plan post-market activities required by MDR with respect to:
- Risk Management and related planning
- Post-Market Surveillance and Post-Market Follow-Up (PMCF)
- Periodic reports, Vigilance, ad-hoc reporting
- Regulatory responsibilities of all economic operators including communication with competent authorities, notified bodies, economic operators, customers etc.
- Recall, Field Safety Corrective Actions (FSCA), Corrective And Preventative Action (CAPA)
- Regulatory relevance of change control to QMS, design and manufacturing
- Extent of readiness for audits/reviews/assessment
- Put into effect gained knowledge concerning implementation of MDR
  requirements into your organization, e.g. in projects for CE-marking
- 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 signed
* 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

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