The Design History File for Medical Devices

About this course

From demonstrating the critical regulatory inputs from standards, essential requirements and product specific expectations to the establishment and translation of performance requirements the Design History File is the window to all of your product specification decisions. The course outlines how to create a Design History file and deals with the content, structure, meetings, decisions and sequence and interactions necessary to generate a regulatory compliant history.

Course outline

• Evaluate the regulatory requirements for a design history file and see how they interact with your design, validation, change and post-market processes
• Establish the importance of the Design Plan to demonstrate that all critical inputs have outputs and are critically reviewed through product testing, technical review and Design review.

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

The tutors for this course are as follows:

• 

  James Pink
  Medical Devices, Vice President
  

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

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