Clinical Governance




Click image for Medilink


 

The Company, ComputerGen Implants Limited was launched in 1998 at the Medilink Meeting in York U.K. This Association is a non profit organisation linking Industry, Academia and the British National Health Service.

The introduction of any new technology in the healthcare market is subject to stringent international regulations and legislation in the public interest.

The regulations pertaining to the use of customized implants within the European Union and published by the Medical Devices Agency.


Click for Medical Devices Agency web site

To avoid a conflict of interest, objective evaluation of this technology will require a linkages between academia, industry and the National Health Service, with a transparency, and divorce from declared commercial development in the following categories:

Research and Development
Clinical Audit
External Peer Review
Multicentred studies
International Research and Development

We are currently working with partners in the European Union in an international research consortium and hope that the merits of this technology will influence central funding at national level with the formation of centre of excellence in Engineering Assisted Surgery.

In the United Kingdom the evaluation of this technology has been given a "C" grading by the Academy of Medical Royal Colleges SERNIP, the Safety and Efficacy Register for New Interventional Procedures, which will permit a prospective study with external peer review.



Following the earmarking of significant funding, it is planned that an International Centre of Excellence in Engineering Assisted Surgery will be created in 2006 in the United Kingdom.

 

Clinicians interested in taking part in this project should correspond by email.