EU Medical Device CE Marking - AdvancedPrint
Part of our Medical Device Qualified Person Qualifications
£1500.00 excl. VAT – £1800.00 inc VAT (10% discount available for additional delegates booking from the same company)
About this course
Builds upon the understanding and implementation courses for CE marking and examines the specific regulatory requirements surrounding clinical strategy, product design, product manufacture and post market regulatory responsibilities.
NOTE – As the regulatory framework is likely to change in the coming 18 months the course also discusses the potential impact of these changes.
- Critically evaluate the requirements for clinical investigation and evaluation – Annex X.
- Critically evaluate the use of harmonised standards and essential requirements – Annex I.
- Explore the total requirements for pre-market registration – Articles 2, 4, 6, 14.
- Explore the total requirements for post-market product surveillance and vigilance – Article 8, 10.
AMP Technology Centre, Sheffield
We have selected the Advanced Manufacturing Park (AMP) Technology Centre near Sheffield as its location and environment are ideal to centralise and control our services. Based in a region well known for its expertise in healthcare manufacturing technologies and supported by clinical and academic excellence, the Centre provides an ideal location for business events, meetings, seminars, training events and small scale trade shows. With free parking, proximity to the M1 and M18, and within an hour’s drive of Leeds, Manchester, Sheffield, Bradford, Nottingham and Leicester, it is a convenient and accessible location.
The AMP has been designed to accommodate a range of manufacturing related activities, from the work of fledgling engineering and technology companies to the University of Sheffield’s collaboration with some of the world’s foremost advanced manufacturing technology businesses, such as Boeing and Rolls Royce.
We have a block booking of bedrooms at both the Aston Hotel Sheffield and the Holiday Inn Rotherham-Sheffield at a specially negotiated bed and breakfast rate. Hotel reservations should be made directly with the hotel. Please quote ‘NSF’ at the time of booking.
Any charges made by the hotel as a result of you not taking up your reservation for any reason will remain your responsibility, therefore please ensure that you are aware of the hotel’s cancellation policy.
Aston Hotel Sheffield, to book please call the hotel on +44 (0) 1142 615690, quoting ‘NSF’.
Holiday Inn Rotherham-Sheffield, to book please call the hotel on +44 (0) 1709 830630, quoting ‘NSF’.
We believe that our team of experts are the best available. Not only have they got years of experience in the industry, but they are committed to tutoring and helping those inside the industry to improve and raise the standards. We understand that you attend courses to learn about the latest regulations and to get your questions answered.
Our expert for this course is James Pink.
What you've said
Having attended the week long Regulatory Strategies for Medical Devices module delivered by NSF Health Sciences in October 2013, I cannot recommend this course enough. It is suitable for professionals newly entering the medical devices regulatory industry, in order to provide broad understanding on each stage of the regulatory process, and is equally suitable for those wishing to update their existing knowledge base, due to the ever changing and complex medical device laws and regulations. The course material provided is extensive, however, pitched at the perfect level by the excellent tutor, in order to aid quick and thorough learning and facilitate some interesting group discussions. Very highly recommended!