About this course
This course is for all those involved within the design and development of medical devices.
The course provides a detailed overview of the requirements from ISO 13485 and FDA CFR 21 Part 820 for design control (an essential component to demonstrate a devices overall safety and effectiveness).
The principles of design control will be taught throughout the course. The course aims to provide delegates with the necessary tools and techniques to design and develop devices that meet international regulatory expectations and provide good design assurance.
We will provide you with a clear overview of how to link medical device regulatory safety and performance principles to the common acceptable methods used to demonstrate design performance.
By the end of the course you will be confident in implementing design control against international requirements and, more importantly, you will have the tools necessary to evaluate the effectiveness of your process to meet international medical device regulations.
Who Should Attend
- Design engineers
- Subject matter experts
- Quality and Regulatory Personnel
- Consultants wishing to advise organisations on design of medical devices
- Notified Body and Regulatory agency review personnel.
- Pharmaceutical Qualified Persons with Medical Device responsibility
- Pharmaceutical Qualified Persons moving into the Medical Device Indusrty
Venue
AMP Technology Centre, Sheffield, UK
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)114 254 1200
Fax: +44 (0)114 254 1201
Tutors
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.
An NSF International Company 
