About this course
Understand the implications of the regulatory developments in Europe and the proposed revision of the FDA Blue Book 510(k) Guidance in the Biological Evaluation of Medical Devices. The ISO 10993 series of standards, covering biological evaluation of medical devices, is well established and regulatory authorities worldwide require compliance. In Europe compliance with the EN ISO 10993 standards is the easiest way to meet the essential product safety requirements of the Medical Device Directive. The development of a European Regulation for Medical Devices is ongoing and significant changes are known or expected. New parts in the ISO 10993 series are being developed, e.g. ISO TS 10993-22, Guidance on Nanomaterials, and many existing parts are being revised. The key ISO 10993- :2009 is now up for 5 year systematic review and some revision is likely. This interactive seminar will provide opportunities for discussion, to have your questions answered, and realistic group exercises on these standards.
Who Should Attend
This course is essential for any professionals responsible for product safety within medical devices. Development engineers, auditors and QARA professionals may also find the extensive background on biological safety a critical knowledge gap that this module will fulfill.
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
An NSF International Company 
