BIOLOGICAL
EVALUATION OF
MEDICAL DEVICES

Conference Date: 18-19 Oct 2010
Conference Ref: N10-8410
Fee: £1000 + VAT
Venue: The Rembrandt Hotel, London

Please note that the details of this meeting are combined with the Drug/Device Combinations programme and when you download the e-brochure you will need to scroll down to view the agenda. Discounted rate if booked with Drug/Device and Device/Drug Combinations on 20-21st October 2010.  Click here to find out more

Overview

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, or existing parts revised 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-ordinates 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.

WHO SHOULD ATTEND

Medical Device personnel from the following departments: Regulatory Affairs, R & D, Product Safety/ Toxicology, Analytical Chemistry, Material Specialists, Risk Assessment and Risk Management. It will be beneficial to personnel from Regulatory Authorities, Notified Bodies and CROs supporting the Medical Device Industry.

Speaker

Dr John C T Lang, DABT, Managing Director, Medwise International Consultancy Ltd.

Click here to book your place on this important Annual event.