Medical Devices Clinical Evaluation – Step by Step

About this course

Learn how to undertake a critical review of scientific and clinical data in order to present a robust clinical evaluation of your device technologies clinical performance. This course will enable you to understand the disciplined approach required to meet the requirements for clinical evaluation defined within 93/42/EEC Annex X and identify when clinical data is sufficient and not sufficient to support your medical device.

Course outline

• Evaluate the requirements from Annex X of 93/42/EEC relating to Clinical Evaluation
• Determine the steps required to ensure that a clinical evaluation generates the appropriate data by establishing inclusion and exclusion criteria
• Understand the importance of using databases, reference tools and good documentation practice to ensure critical evaluation of clinical literature
• Establish how to determine if clinical data is relevant
• Create clinical evaluation procedures that will ensure you are compliant with Annex X

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 experts for this course are:

• 

  Janette Benaddi
  Medical Devices Consultant
  

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

What you've said

This is a new course for NSF-DBA and we will soon be able to provide you with feedback from our Medical Device programme.