For the in-vitro diagnostic sector these new regulations will bring about major shifts in areas such as classifaction, performance evaluation and clinical evidence. The new regulations will be fully applicable in 5 short years. Will your devices be ready?
Some key elements of the new regulations include:
- Tighter pre-market controls on high risk devices and a more stringent approach to the conducting of clinical evaluations and clinical trials
- An introduction of a risk based classification system which will apply to all in vitro diagnostic medical devices
- This course will cover all of these key elements, plus more. You will learn about key timelines that you need to be working to and what steps need to be taken next.
MedilinkWM, in conjunction with Acclaim Biomedical Consulting, is offering a one day workshop exploring the new European Regulations for In Vitro Diagnostics. With over 20 years experience in Medical Devices, Acclaim Biomedical Consulting are best placed to support and advise on the regulatory changes and the impact these will have on existing practice.
- Risk based product classification
- Conformity assessment
- Clinical Evaluation
- Obligations of economic operators
This course aims to provide delegates with the insight and tools required to plan and implement an organisational strategy for continued access to the European Markets. The course will review critical elements of the new regulations in great depth and will run as a full day, interactive course.
From this workshop you will take away our specially made checklist, that will assist you with making sure that your organisation is working in line with the new Regulations
Who should attend?
The course is designed for business leaders with a good working knowledge of the current regulatory requirements
Member fee: £140
Non Member fee: £190
Register before Friday 2 June to receive 10% early bird discount
For more information or to register your place, please contact Vanessa Bailey by emailor by calling 0121 452 5630.