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
All prices exclude VAT
Once we have received your booking form you will receive a confirmation email and an invoice will follow.
How to find IGEM House:
Conveniently located off Junction 23a/24 offering easy access to Derby, Nottingham and Leicester. The nearest train station is East Midlands Parkway which is 3.4 miles away. To help plan your journey, please click here to visit the venue’s website. Complimentary on-site car parking is available.