HI-MT2 Training CE Certification of Your Medical Device – A Practical Guide

Get an overview of the regulatory requirements and learn how to implement these in your development process!| 1 day

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 a proven competent team member.

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About the CE Certification of Your Medical Device

The CE Certification of Your Medical Device training 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.

Subjects of the CE Certification of Your Medical Device

The following topics will be discussed during the CE Certification of Your Medical Device training:

  • The product development process showing the correlation of regulatory requirements, project activities and deliverables
  • Verification and Validation
  • Usability Engineering
  • Clinical Evaluation

Results of the training CE Certification of Your Medical Device

During the CE Certification of Your Medical Device training you will learn:

  • 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

For whom

The training 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
  • Professionals with a master or bachelor level, or equivalent knowledge gained through experience.

Setup training

The training CE Certification of Your Medical Device consists of 1 day from 9 am to 5 pm.

Locations, dates & schedule

This training is offered in our 1.5-meter classrooms, online or hybrid. Moreover, we have both in-company as free enrollment possibilities.

Eindhoven: High Tech Campus 29
Enschede: The Building, Hengelosestraat 500

Dates 2021
Location: Enschede
June 15

Location: Eindhoven
November 18

Investment training

The investment for the training is €795 per participant, excluding VAT. Included is the training day, course material, daily lunch and refreshments

Teachers

Jolande Koobs
Experienced Project Manager with a demonstrated history of working in the medical device industry. Project management professional and Regulatory specialist skilled in managing the development of (software) products with a strong affinity for Quality assurance and Regulatory affairs.

Lisette van Steinvoren
Projectmanager with several years of experience in –medical device- product development within both multinationals & SME’s, Lisette has a background in Applied Physics & Innovation Management from the University of Utrecht. She is Six Sigma Black Belt and IPMA-C certified. Working as Sr. Project Manager Medical at Holland Innovative.

Certificate / diploma

Participants who have followed the full training receive a certificate of participation.

Method of teaching

The training CE Certification of Your Medical Device is offered as an in-class course, but any other form is open for negotiation. We are able to offer offline, online and hybrid courses. In the case of one or more non-Dutch speaking participants, the course is given in English.

Group size

Maximum group size: 10

After the training, holland-innovative optionally offers on-the-job coaching to further improve and implement the medical device development process and practices in your company. This course can also be given within your company, tailored to your specific needs. The course can be extended with topics, like:
• CE certification of medical device software
• Project Management
• Design for Six Sigma

Persoonlijk opleidingsadvies?

Wilt u graag meer informatie over deze opleiding? Onze deskundige opleidingsadviseurs helpen u graag verder! Zij zijn telefonisch bereikbaar van maandag t/m vrijdag van 08.30 tot 17.00.

T: +31 (0)40 851 4610
E: academy@holland-innovative.nl

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Over de Holland Innovative Academy

Holland Innovative helpt bij het ontwikkelen van de competenties van u en uw collega’s om uw organisatie te versterken en groei te creëren. Samen met gerenommeerde expertisecentra zoals de Technische Universiteit Eindhoven, Universiteit Twente, Technische Universiteit Delft en de Universiteit van Stuttgart organiseren we opleidingen, trainingen en masterclasses in Projectmanagement, Product & Procesontwikkeling, Reliability, Data Science en MedTech. We bieden zowel open inschrijving als incompany trainingen; op maat gemaakt om volledig  aan de behoeften en de strategie van uw organisatie te voldoen. Het koppelen van deze trainingen aan praktijkervaring is belangrijk om de effectiviteit te maximaliseren. Waar mogelijk worden uw eigen cases/data besproken tijdens onze training en/of verder verkend door coaching on the job, projectparticipatie en ook in de User Groups.

Bekijk ons complete trainingsaanbod in de Holland Innovative Academy