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