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 1, 2, 17 and 18. In addition, a major revision of ISO 10993-1 is near completion (FDIS) which incorporates 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.

Event Website : BIOLOGICAL EVALUATION OF MEDICAL DEVICES - Understand The New Approach To Biological Evaluation And Its Practical Application

Location:	Harrington Hall Hotel, London
Contact:	Leigh White leigh@management-forum.co.uk 44 1483 730071
Organization:	Management Forum Ltd
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