Implementation of the Medical Device Regulation training course

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Beschrijving

This course will help you to implement the requirements of European Medical Device Regulation (MDR) to obtain and maintain CE marks for your product, giving you access to a market with 500+ million people. Find out best practice for assembling Technical Documentation and QMS when placing Medical Devices (MD) on the European Union market.

The course will also review the requirements of, and relationship between, the legal manufacturer, subcontractors/suppliers, notified bodies (e.g. auditing), and economic operators (importers, distributors, EU Representatives) according to their obligations by MDR.

Who should attend?

The course is especially suitable for:

  • RA, QM, and QA professionals w…

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This course will help you to implement the requirements of European Medical Device Regulation (MDR) to obtain and maintain CE marks for your product, giving you access to a market with 500+ million people. Find out best practice for assembling Technical Documentation and QMS when placing Medical Devices (MD) on the European Union market.

The course will also review the requirements of, and relationship between, the legal manufacturer, subcontractors/suppliers, notified bodies (e.g. auditing), and economic operators (importers, distributors, EU Representatives) according to their obligations by MDR.

Who should attend?

The course is especially suitable for:

  • 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

Please note: This course will not cover implementation for In Vitro Diagnostics or concentrate on devices with specific requirements.

Prerequisities

Participants must have a good understanding of the requirements in the MDR, which is conveyed by our 1 day Requirements course or our MDD to MDR transition course.

Participants 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. 

Delegates will be able to:

  • 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

Combination discount MDR training courses

Attending several medical device courses is associated with special discount.

1. Transition or Requirements MDR - IVDR € 800

2. Implementing CE Marking MDR - IVDR € 2.150

Combination of course 1 + 2 = € 2.950 - € 100 discount= € 2.850

In-house training courses

We can deliver this training course to your team in-house. Training in-house allows you to save on each individual delegate and also cut out travel and accommodation expenses, which can be significant.

For more information about the in-house training or to request a quote, please contact our Training Advisors.

Practical information

  • It's a 3-day course
  • The training will be delivered in the Dutch language (or in English when by all delegates required/approved)
  • The materials will be provided in English
  • Lunch and drinks are included

For further information regarding reduced rates at the hotel where the training is being conducted please contact our Training Advisors.

BSI biedt een grote diversiteit aan praktijkgerichte trainingen. Door onze centrale rol in de commissies waarin de normen tot stand komen, kennen wij de inhoud van een norm tot in detail en zijn wij in staat om u informatie uit de eerste hand te leveren.

Daarnaast weten wij als wereldwijde certificatie-instelling precies hoe organisaties met de normen in hun eigen organisatie om kunnen gaan. Het onderscheidend vermogen van de trainingen wordt o.a. gekenmerkt door de focus op praktijkgericht en effectief leren middels interactieve opdrachten.

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