About this course
Participate in a day’s seminar outlining the current methods of undertaking medical device biological safety evaluation.
Come and listen to the best in the industry explain and outline the challenges, solutions and considerations impacting medical device design and manufacturing organizations in light of recent high profile material safety concerns.
Over the last 5 years there has been a deepening concern that the method of understanding the safety of medical devices when considering biological risks has not encouraged the use of the most up to date scientific, engineering and regulatory methods. Several high profile failures relating to surgical implants have raised the level of concern from the US FDA, European Commission and subsequently the authorities responsible for overseeing medical device safety around the world.
Standards setting groups have worked hard to bring standards into line with the latest considerations for risk management, testing, analytical methods and on-going control of materials and devices and there have been significant changes in how the assessment of clinical benefit over risk should be undertaken by manufacturers. This has culminated in the need for better risk management, better knowledge of the actual failure modes that can have an impact on biological stability when interacting with the human body and a better understanding of the tools and techniques to be used when validating the design, process and clinical efficacy of a medical device throughout its lifecycle.
Course outline
This is a new course offering for Medical Devices and part of our Qualified Person programme for Medical Devices.
For more information please call our team on +441142 541270
E-mail our training and education team at: [email protected]
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 
