Technical documentation for medical devices

Do you want to ensure that your technical documentation meets the highest standards and that the review process with the notified body is as smooth and efficient as possible?

This course is tailored for RA and QA specialists who are relatively new to development projects for medical devices. You will gain a clear understanding of how technical documentation is built throughout the development process – from concept to market approval. We will cover requirements, common pitfalls, and proactive strategies to minimize delays and streamline the review process.

The goal? To get your product to market faster, help patients, and drive business success.

Topics

• How technical documentation is created throughout the development process
• MDR Annex II & Summary of technical documentation
• How technical documentation is updated after the product has been placed on the market

Target group
This course is designed for RA or QA specialists who are relatively new to development projects for medical devices.

Educational goals

After completing the course, participants will have a solid understanding of technical documentation in accordance with MDR. They will learn how technical documentation is developed throughout the product development process, which key standards and guidelines must be followed, and how the documentation is continuously updated throughout the product lifecycle.

Participants will also gain insight into how to effectively compile and summarize technical documentation according to Annex II to facilitate a smooth review process by the notified body.

Upon successful completion of the course, participants will receive a course certificate.

Recommended prior knowledge
No prior knowledge is required.

Course presentations
Course material will be in English, verbal presentation and discussions in Swedish.

Course leader
Caroline Ehrenborg, Senior Quality and Regulatory Consultant