CE Certification of Your Medical Device – A Practical Guide

Getting started with CE certification of your medical device

CE certification of your medical device is certainly not something you would do on a Friday afternoon but is often underestimated, especially now the regulations have been updated to the MDR.
You need a.o. to plan your development, perform risk assessments, test your product and provide documented evidence. You have to set-up your technical documentation, have a quality management system in place with approved suppliers and have proven competent team member

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This course “CE certification of your medical device” will give you an overview of the applicable regulation and standards and will provide you with practical knowledge on when and how to implement the regulatory requirements in your product development process and your organization.

A selection of subjects that will be addressed:

  • The product development process showing the correlation of regulatory requirements, project activities and deliverables
  • Steps in CE certification according to the MDR, using applicable harmonized standards
  • Quality Management System based on ISO 13485
  • Safety Risk Management according to ISO 14971
  • Verification and Validation
  • Usability Engineering
  • Clinical Evaluation

Audience group
The course “CE certification of your medical device” is suited for:

  • Members of a medical device development team, like project managers, development engineers, operational buyers, quality and regulatory engineers
  • Management of medical device manufacturers and suppliers.

The course is suited for professionals with a master or bachelor level, or equivalent knowledge gained through experience.

CE certification of your medical device

Location and investment:
Eindhoven: High Tech Campus 29
Enschede: The Building, Hengelosestraat 500
The investment for the training is €795 per participant, excluding VAT. Included is the training day, course material, daily lunch and refreshments

Course duration and number of participants:
One day from 09.00 to 17.00. Maximum group size: 10
Our training courses are given in Dutch as standard. In the case of one or more non-Dutch speaking participants, the training is given in English.

Dates 2021
Location: Enschede
June 15

Location: Eindhoven
November 18

Trainingen van Holland Innovative worden volledig remote en online aangeboden volgens het Live Online Interactive Training format (LOIT). Deze ontwikkeling is een logische stap in de contact-beperkende maatregelen omtrent het COVID19-virus en wordt door Holland Innovative aangeboden voor alle trainingen en workshops in 2020. Wij zijn continu bezig met innovaties in kennisontwikkeling: van challenge based learning tot digitale leeromgeving en volledig remote. Neem contact op voor meer informatie over LOIT, we helpen je graag verder.

Instructors:
Sr. Project Manager Medical Devices Jolande Koobs and Lisette van Steinvoren.

Questions?
Do you have a question about one of our courses? Contact us for free advice about the possibilities.
T: +31 (0)40 851 4610
E: academy@holland-innovative.nl