With some substantial revisions and updates currently being made to the ISO 10993, Informa's 6th Annual Biocompatibility Testing and Evaluations for Medical Devices is essential for first-hand practical industry feedback, FDA guidance update and Notified Body expectations on key biocompatibility requirements. The conference will provide the latest updates to ISO 10993 including biocompatibility of respiratory devices, updates for absorbable implants, changes to ISO 10993-17 to include Thresholds of Toxicological Concern and revision of ISO 10993-5 and new round robin on cytotoxicity.
Highlights include:
- Current status and latest updates to ISO 10993
- FDA guidance update: Use of ISO 10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing' (April 2013)
- Interactive Experience Exchange: Sharing experiences with FDA requirements and expectations for biocompatibility testing and evaluations compared to Europe
- Notified Body perspective: Practical advice on successful biocompatibility submissions
- Case study: Practically implementing ISO 10993-17 allowable limits for leachable substances
- Exploring Threshold of Toxicological Concern (TTC) initiatives for medical devices as a new element to ISO 10993-17
- Practically implementing the chemical characterisation risk assessment approach and complying with ISO 10993
- Assessing the current status of revision of ISO 10993-4 on blood compatibility and successful strategies for haemocompatibility testing and evaluations
- Notified Body perspective: Successfully managing change control: Re-evaluation of biocompatibility data in the case of product changes
- Practically managing change control and impact on biocompatibility testing and evaluations
- Managing the biological evaluation of nanomaterials and assessing the current regulatory environment
- Practically carrying out biocompatibility testing and evaluations for drug device combination products
- Working successfully with contract laboratories and service suppliers for biocompatibility testing