Understanding Product Validation for Medical Devices

About this course

A medical device manufacturer must demonstrate safety and function of its product through formal test and evaluation methods. This course outlines the regulatory requirements for product validation and introduces the formal expectations from regulatory agencies relating to the validation of a product. Focussing upon the development of Harmonised standards and product specific standards this course will provide a significant overview of how to address the critical product verification and validation requirements for regulatory submission.

Course outline

• Review and implement the fundamentals of Product Validation within a medical device organisation
• Evaluate how medical device product specific standards are developed and subsequently adopted by regulatory agencies
• Apply the logic required to systematically demonstrate a product has been appropriately validated for its function
• Determine the procedures required by an organisation to ensure that company developed test methods are based upon robust science, engineering and quality assurance principles.

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

This a new course for 2014