- The product development process showing the correlation of regulatory requirements, project activities and deliverables
- Steps in CE certification according to the IVDR, using applicable harmonized standards
- Quality Management System based on ISO 13485
- Extensive explanation of ISO13485 procedures with examples on how to apply this to your own organization, and how this influences the work of your engineers
- Safety Risk Management according to ISO 14971
- Verification and Validation, including the analytical performance requirements of the IVDR
- Usability Engineering
- Performance Evaluation and it's three pillars: scientific validity, analytical performance, and clinical performance
- Extensive explanation of IVDR technical file requirements and supplementary information from applicable standards
HI-MT4 CE certification of your IVD medical device
Get an overview of the regulatory requirements and learn how to implement these in your development process.

With this course you’ll learn:
- The product development process showing the correlation of regulatory requirements, project activities and deliverables
- Steps in CE certification according to the IVDR, using applicable harmonized standards
- Quality Management System based on ISO 13485
Teaching professionals.

Lisette van Steinvoren - Stamsnijder
Competence Lead MedTech & Sr. Project Manager Medical
Lisanne Karbaat
Project Manager Medical DevicesTraining information
- Enschede
- 1 module of 1 day
- 21-06
Investment
The investment for the training is €795 per participant, excluding VAT.
Included is the training day, course material, daily lunch and refreshments

Curious?
Talk to our academy advisorAbout the training CE Certification of Your IVD medical device
The course CE Certification of your IVD 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.
Training: CE Certification of your IVD Medical Device.
Outcome
The CE certification of your medical device is certainly not something you would do on a Friday afternoon but it is often underestimated, especially now the regulations have been updated to the IVDR.

You need to a.o. 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 members.
CE Certification of Your IVD Medical Device
Yes, I'm joining.
What you’ll learn.
Block 1 - day 1
What you'll learn in this course
Practical information.
For whom
The training CE certification of your IVD medical device is suited for:
- Members of an in vitro diagnostic medical device development team, like project managers, development engineers, operational buyers, quality, and regulatory engineers.
- Management of IVD manufacturers and suppliers
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
Enschede – Hengelosestraat 500 (Building The Gallery)
Dates 2023
To be determined
Group size
A maximum of 10 participants
Relevant courses.
HI-MT1 Fundamentals in Medical Device Development
MedTechLearn how the expertises regulatory, design for six sigma and project management cooperate as a team to successfully complete the design of the medical device.

- Eindhoven/Enschede
- 3 modules of 1 day
HI-MT2 CE Certification of your Medical Device
MedTechGet an overview of the regulatory requirements and learn how to implement these in your development process.

- Enschede
- 1 module of 1 day




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