About this course
Two day course taking you through the specific expectations of software as a medical device including the technical file elements, validation methods and harmonized standards you will need to understand in order to demonstrate that your software fulfills the essential requirements in Europe. This course addresses the design control requirements often referred to as the software development lifecycle, as well as the quality management system specifics that most people unfamiliar with software quality assurance will need to know. The course explains the ‘what’ in terms of regulatory and quality system requirements and works hard on the ‘how’ by leaving you with simple project plans, checklists and draft procedures that you can adapt for your business. A truly practical ‘how to’ course.
Who Should Attend
This course is delivered in-house and recommended for:
- Medical Device Product Managers
- Medical Device Product Designers
- Medical Device Product Testers
- Medical Device Software Product Developers
- Medical Device Quality Managers
- Medical Device Quality Engineers
- Medical Device Regulatory Personnel
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 
