Understanding Design Control for Medical Devices

About this course

Address the requirements for design control of medical devices and discover the data necessary to support market approval for your device. Aligned to the requirements from Annex II of 93/42/EEC and ISO13485 Section 7.3 this course aims to ensure you have the appropriate processes to to demonstrate product safety and performance within a design process.

Course outline

• Evaluate the design requirements defined in 93/42/EEC and ISO13485 – Compare implementation strategies for a design process in your own organisation
• Establish the documentation requirements for capturing design input that addresses both product safety and functional performance – plan the necessary records within a QMS, design history and technical file
• Discover the relationship between Risk Management, Harmonised Standards and the Essential Requirements in Annex I
• Evaluate the planning, input, output, verification, validation and design review activities associated with good design control

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.

• 

  James Pink
  Medical Devices, Vice President
  

  • [email protected]
  • +44 (0) 1143 600868
• 

  Henry Sibun
  Medical Devices Consultant
  

  • [email protected]
  • +44(0) 1143 600868

What you've said

James, thanks for your time yesterday. I had received very good feedback on the training and it has helped a lot in my efforts of trying to establish a better process.

Guarav Mehta - Reckitt Benckiser