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2020 - Biocompatibility Testing for Medical Devices
Date2020-05-07 - 2020-05-08
Deadline2020-04-27
VenueSan Francisco, CA, USA - United States 
KeywordsISO 10993-1; ISO 14971; Principles of toxicology
Topics/Call fo Papers
The areas that will be discussed in the seminar will include the following topics throughout the agenda:
History of ISO 19993-1
Overview of collateral standards, i.e., 10993-X
Risk based approach (for Biocompatibility)
Review of ISO 14971 Risk management file
Biocompatibility evaluation endpoints
Endpoint assessment vs. testing
Endpoint consideration: Test specific
Chemical testing: Extractables and Leachables
Toxicology assessment
History of ISO 19993-1
Overview of collateral standards, i.e., 10993-X
Risk based approach (for Biocompatibility)
Review of ISO 14971 Risk management file
Biocompatibility evaluation endpoints
Endpoint assessment vs. testing
Endpoint consideration: Test specific
Chemical testing: Extractables and Leachables
Toxicology assessment
Other CFPs
- Quality Control Laboratory Compliance - cGMPs and GLPs
- REACH and RoHS Compliance: Protecting Revenues with Advanced Compliance
- Latin America – Understanding Regulatory Compliance Requirements Across the Life Science Industry (Pharmaceuticals, Biologics, Medical Devices, IVDs)
- Risk Based Internal Auditing (RBIA)
- Managing Your FDA Inspection: Before, During and After
Last modified: 2020-01-14 01:25:47