TRAINING
Preparing the QMS for the IVDR
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 the key updates required to get your QMS ready for the IVDR. Most companies are complied to the ISO 13485 and have been audited. It has the best practices, but in the IVDR there are additional requirements and QMS's are all about details. You will learn what you need to do more.
Program overview
Duration: 2 hours (virtual or customized in-house, to be determined in consultation)
- Understanding the IVDR requirements for the QMS
- IVDR implementation from an ISO view
- IVDR implementation according to the regulation
- Implementation overall within your organization
- Understand the connections between elements of the quality system
- Final remarks
Who should attend?
- Senior Management
- Regulatory Affairs Managers, Quality Managers and/or Directors
- Clinical director
- R&D, Product Development, Manufacturer, Operations and Marketing Managers
- International registration department
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.