Medical Devices - Getting started with CE Certification

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 advisor

About the training Medical Devices - Getting started with CE Certification

The Medical Devices - Getting started with CE Certification 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 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: Medical Devices - Getting started with CE Certification.

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.

Medical Devices - Getting started with CE Certification

Yes, I'm joining.

What you’ll learn.

Program

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

Relevant courses.

HI-MT3 In Vitro Diagnostic Medical Devices - Getting started with CE Certification

MedTech

Get an overview of the regulatory requirements and learn how to implement these in your development process.

Lisanne Karbaat

Project Manager Medical Devices

1 day

HI-MT1 Fundamentals in Medical Device Development

MedTech

Learn how the expertises regulatory, design for six sigma and project management cooperate as a team to successfully complete the design of the medical device.

Wim Schouten

Sr. Project Manager

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

The training is suited for 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: