MPD training course: Regulatory affairs for medical devices in the European Union
Medilink East Midlands, together with Medical Device Consultancy (MDC) are offering a one day training course which will provide delegates with an intermediate to advanced understanding of regulatory affairs for Medical Devices in the European Union.
This course will provide answers and practical methods by answering the following questions:
- Do you use the 'Blue Guide'? What is it and why is it important?
- What matters more: Best practice, regulations or legal requirements, and why?
- Do you know how to determine the 'Direction of Travel' for medical device regulation?
- What else does a CE mark really mean?
- Does usability really matter? What is 'Human Factors Engineering'?
- How do you handle software? Are you compliant?
- How do you undertake clinical evaluations and investigations that make a difference?
- What is in the proposed new Regulations and what matters to you?
By attending this course you will improve your day-to-day management of regulatory affairs, learn about the changes to roles and responsibilities of key stakeholders and understand where to find and use guidance that helps you achieve full compliance.
Member cost: £ 150
Non-Member cost: £ 215
***EARLY BIRD OFFER*** book before 5pm on Friday 21 April and members will pay £120 and non-members will pay £170
All prices are excluding VAT
Once we have received your booking form, we will email you to confirm your booking and send you an invoice.