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.
To view the programme and further information click on the Event Brochure PDF below.
To register your place, please complete the ‘Book Online Now’ form below.