In Vitro Diagnostic Medical Devices - Getting started with CE Certification

Training information

Investment

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

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

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About the training In Vitro Diagnostic Medical Devices - Getting started with CE Certification

The course In Vitro Diagnostic Medical Devices - Getting started with CE Certification 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:

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

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.

Lisanne Karbaat

Project Manager Medical Devices

Lisanne is an enthusiastic and thorough manager with extensive knowledge about regulatory requirements. She holds a masters degree in Biomedical Engineering and has several years of academic research experience using various in vitro diagnostic technologies. Her goal in medical projects is to let the build-up of documentation support the development of a device, so that people can bring safe and good products faster to the market.

Training: In Vitro Diagnostic 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 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.

In Vitro Diagnostic Medical Devices - Getting started with CE Certification

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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 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

Relevant courses.

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

HI-MT2 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.

Lisette van Steinvoren - Stamsnijder

Competence Lead MedTech & Sr. Project Manager Medical

1 day

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

The course 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: