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.

CE certification of medical device - opening image

With this course you’ll learn:

  • 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

Teaching professionals.

Lisette van Steinvoren - Stamsnijder

Lisette van Steinvoren - Stamsnijder

Competence Lead MedTech & Sr. Project Manager Medical
Lisette is a dedicated project manager with several years of experience in innovative product development within both multinationals and SMEs. She is passionate about creating relevant products, especially when they are health and environmental related. Lisette has a background in Engineering Physics & Innovation Management. She is Black Belt and IPMA C certified.

Training information

  • Hybrid
  • 1 module of 1 day

Investment

The investment for the training is €795 per participant, excluding VAT.

Included is the training day, course material, daily lunch and refreshments 

About the training 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.

Training: CE Certification of Your Medical Device.

Outcome

The 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.

MTs - outcome

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.

CE Certification of Your Medical Device

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What you’ll learn.

Block 1 - day 1

What you'll learn on day 1of the course

  • 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

Practical information.

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, and professionals with a master or bachelor level, or equivalent knowledge gained through experience.

Certificate

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

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

Location & Dates

Locations 
Eindhoven – High Tech Campus 29 
Enschede –  Hengelosestraat 500 (Building The Gallery) 
 
Dates 2022
Location: Enschede
Day 1: June 22

 
Group size 

A maximum of 10 participants 

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Take the next step in your personal development.