About this course
Learn how to undertake a critical review of scientific and clinical data in order to present a robust clinical evaluation of your device technology’s clinical performance. This course will enable you to understand the disciplined approach required to meet the requirements for clinical evaluation defined within 93/42/EEC Annex X and identify when clinical data is sufficient and not sufficient to support your medical device.
Who Should Attend
Development, regulatory and clinical personnel involved in the formulation of clinical investigations, evaluations and post market clinical follow-up of medical devices. The medical devices requirements are placing a major emphasis upon clinical data requirements for devices, therefore programme managers, marketing and senior managers will also benefit from this module in that they will be able to understand the clinical requirements necessary for their devices and plan an appropriate commercialization strategy.
Venue
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.
Hotel Accommodation
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’.
Venue Address and Contact Details
AMP Technology Centre
Advanced Manufacturing Park
Brunel Way
Rotherham
S60 5WG
England
Tel: +44 (0)1142541200
Fax: +44(0)1142541201