TRAINING
Technical documentation
There is an enormous amount of work required to transition from the IVDD to the IVDR, manufacturers need to recognize that the IVDR is more complex and detailed and will, therefore, require more recourses to maintain as well as implement.
The aim of the course is to understand how to compile an IVDR compliant Technical File. You will learn what you need to know before you get started to prepare a technical file. How to get started and agree an approach with your team and then compiling it, which is the part with the most comprehensive information. The technical documentation is all about detail, this is your proof that you meet the requirements.
Program overview
Duration: 2 hours (virtual or customized in-house, to be determined in consultation)
- What do you need to know before you start to prepare a Technical File?
- How to get started?
- What are the requirements?
- Which data do you need and what sources can you use for new and existing devices?
- Compiling the Technical File (Annex II)
- Keeping the technical file up to date (Annex III)
- General safety and Performance Requirements (GSPR's)
Who should attend?
- Regulatory Affairs Managers, Quality Managers and/or Directors
- R&D, Product Development
There is no prerequisite level for this course.
Costs
- Price on application for customized trainings, tailored workshops, on-location training, train-the-trainer formats or multiple training courses
Please contact us to schedule in-house training, which is also recommended for training multiple colleagues or teams at the same time.