This one-day course is designed for those who need to better understand the IVDD and want to learn what is important to understand for compliance in the IVDR. Comprehensive notes in the form of slides are used in the training plus experience, insights, examples and methods used by the trainers.
The course covers in just one day:
– What is and what is not an IVD
– Who is involved
– Insights into guidance and standards
– What is CE marking and why the ‘Blue Guide’ matters
– An introduction to the IVDD and IVDR, key considerations and timelines
– Understanding the role of economic operators
– How to classify your device under both the IVDD and IVDR
– How to choose a regulatory route to market and why a quality system approach is important
– What is required in technical documentation
– Labelling insights
– Performance evaluation considerations
– IVDD2IVDR planning considerations
Delegate numbers are limited, so the training can be sensitive to individual experience, ability and needs. For full course information and details on the course providers, view the brochure below.
Member cost: £200 Non-member cost: £300 EARLY BIRD OFFER: book before 5pm on Friday 17 August and members will pay £160 and non-members will pay £240
All prices exclude VAT
Once we have received your booking form you will receive a confirmation email and an invoice will follow.