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

Training advice?

Would you like to receive more information about this course? Our program managers can tell you more about it! You can reach them from Monday till Friday from 08:30 till 17:00.

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

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About the Holland Innovative Academy

Holland Innovative helps to develop the competencies of you and your colleagues to strengthen your organization and create growth. Together with renowned centres of expertise such as Eindhoven University of Technology, Twente University, Delft University of Technology and the University of Stuttgart we organize courses, trainings and masterclasses in Project Management, Product & Process Development, Reliability, Data Science and MedTech. We offer both open enrolment and in-company training; tailor-made to fully meet the needs and the strategy of your organization. Coupling these courses with practical experience is important in order to maximise the effectiveness. Where possible, your own cases/data are discussed during our training and/or further explored by coaching on-the-job, project participation and also in the User Groups.

Check the complete training program of the Holland Innovative Academy