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.
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
*We will be holding a training course the day after this course entitled: Medical Devices: Clinical Evaluations, Pre and Post-Clinical Studies. Both courses are complementary to one another and are taking place at the same venue and discounts are available should you or another colleague wish to attend both courses (see information below on the discounts).
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
If you would like to attend both MPD Training Courses (7 & 8 March 18), or attend one yourself and send a colleague to the other, you will save a further 20% on the delegate fee, if you have any queries please get in touch.
All prices are excluding VAT
Once we receive your booking form, you will be sent a confirmation email and an invoice.
How to find iGEM House
The venue is located in Kegworth, 3 minutes from junction 24 of the M1 and 3.4 miles from East Midlands Parkway Train Station. There is free parking available for delegates. For a map and further instructions, please click here.