This one-day course is designed for those who need to better understand the MDD and want to learn what is important to understand for compliance in the MDR. Comprehensive notes in the form of slides are used in the training, but it is the experience, insights, examples and methods used by the well-known trainer, that makes it important to be present as a delegate.
Meet the Trainer
Trevor Lewis has a unique, truly engaging approach that previous delegates have found very effective and especially memorable. He has decades of relevant experiences to draw from, both in industry, as a consultant and as a trainer of regulators around the world on behalf of the European Commission.
Delegate numbers are deliberately limited, so the training can be sensitive to individual experience, ability and needs. Delegates should ideally provide us with a training needs analysis to ensure optimal training and use of time. Where requested white papers, briefings, guidelines and some training materials can be provided to ensure those new to the industry or with less experience can gain the maximum possible insights in just one day of this intensive course.
This one day course covers:
-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, key considerations and timelines
-Understanding the role of economic operators
-How to classify your device under both the 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
-Brief but vitally important comments on clinical evaluation**
-MDD2MDR planning considerations
Trevor Lewis, Director of the Medical Device Consultancy always works with individuals on points of a general nature as much as possible on the day, during breaks, at lunch and immediately afterwards. Those companies or groups requiring a more bespoke training with more practical exercises involved can approach him directly.
If a delegate wants to discuss a specific issue of a confidential nature with Trevor, we recommend this be made clear prior to the event. An appropriate time and place can then be planned for this item to be discussed, usually this should be outside the training day.
**please note comments on clinical evaluation have to be limited and is strongly recommended that delegates wanting in-depth training on this register for other more specific Medilink West Midlands courses.
For more information please contact: Vanessa Bailey, Events Co-ordinator, email@example.com