This one-day course is designed for those who need to better understand the MDD and want to learn what is important for compliance in the MDR. The clock is ticking and time is running out to ensure you are ready for the MDR attend this informative training course.
Comprehensive slides and information will be supplied on the day alongside a wealth of experience, insights, examples and methods.
In just one day the course will cover:
– What is and what is not a medical device
– Who is involved
– Insights into guidance and standards
– What is CE marking and why the ‘Blue Guide’ matters
– An introduction to the MDR plus key considerations and timelines
– Understanding the role of economic operators
– How to classify your device under both MDD and MDR
– How to choose a regulatory route to market and why a quality system approach is important
– What is required in technical documentation
– Labelling insights
– Brief comments on clinical evaluation and MDD2MDR planning considerations
To view the programme and further information (including target audience, learning outcomes and speaker profile) click on the Event Brochure link below.
Member cost: £ 200
Non-Member cost: £ 300
All prices are excluding VAT
Once we receive your booking form, you will be sent a confirmation email and an invoice.
How to find MeetPoint Midlands (previously known as IGEM House), Kegworth:
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.