BIOLOGICAL
EVALUATION OF
MEDICAL DEVICES

Conference Date: 10-11 Dec 2008
Conference Ref: N12-8408
Fee: £1050 + VAT
Venue: The Rembrandt Hotel, London

The ISO 10993 series of standards, covering biological evaluation of medical devices, are well established and regulatory authorities worldwide expect compliance.  In Europe compliance with the EN ISO 10993 standards is the easiest way to meet the essential product safety requirements of the Medical Device Directive.  Several new parts in the series have been developed which promote a new philosophy of biological evaluation (particularly parts 17 and 18).  In addition, a major revision of ISO 10993-1 is under way to incorporate a risk management approach and better co-ordinate the full set of the existing 20 parts in the series.

This interactive seminar will provide practical opportunities for the application of these standards and the new approach to biological evaluation.