- 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
Training information
- 1 day
- 18 November 2024
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 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.
With this course you’ll learn:
- To plan your development
- To perform risk assessments
- To test your product and provide documented evidence
- To set-up your technical documentation, have a quality management system in place with approved suppliers and have a proven competent team member.
Teaching professionals.
Lisette van Steinvoren - Stamsnijder
Competence Lead MedTech & Sr. Project Manager MedicalTraining: 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 it is often underestimated, especially now the regulations have been updated to the MDR.
You need 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.
Program
Relevant courses.
HI-MT4 CE Certification of your IVD Medical Device
MedTechGet an overview of the regulatory requirements and learn how to implement these in your development process.
- 1 day
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.
- 3 days
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
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)
Zeist - Utrechtseweg 48
Dates 2024
Location: Zeist
Session I: 22 May
Session II: 18 September
Group size
A maximum of 10 participants
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Take the next step in your personal development.