The New ISO 10993-18 & Updates to Regulatory Expectations Regarding Chemistry Published 2019-12-16 Download video MP4 360p Recommendations 23:44 The new ISO 10993 - 18 Standard and its Impact on Chemical Characterization of Medical Devices 46:07 Applying a Risk Based Approach to Biological Evaluation of Medical Devices Based on the ISO 10993:18 38:27 Meeting New Challenges in Toxicological Risk Assessment: Pending Updates to ISO 10993-17 36:44 Biocompatibility as a Critical Design Input 48:05 Package Validations – Meeting the Requirements of ISO 11607 18:11 Arsenic - Periodic Table of Videos 59:52 What is Life? - with Paul Nurse 29:25 Medical Device Chemical Characterization 48:32 What Darwin won't tell you about evolution - with Jonathan Pettitt 1:02:57 APACMed White Paper Launch Webinar - Advancing Patient Access to NGS for Cancer in APAC 1:56:10 Sunlight: Optimize Health and Immunity (Light Therapy and Melatonin) 1:06:00 Packaging related nitrosamines in Drug Products 1:03:44 What’s New with Reprocessing Validations for Reusable Medical Devices 1:31:46 Advancing Eye Irritation Assessment with Non-Animal Methods for Chemicals: Progress at the US EPA 40:53 Chemical Characterization According to Iso10993 18 - Dries Cardoen 1:01:36 Biocompatibility Testing, What You Need to Know 31:10 Using the Chemistry of Halogenated Rubber Oligomers in Identifying Unknowns in Extractables Studies 16:17 How to Cope with Rumination: Don't Feed the “Demon” (Default Mode Network) 25:43 How to design an Instruction For Use and validations for EU and US Similar videos 50:36 Navigating Upcoming Changes in Chemical Characterization According to Revised ISO 10993-18 27:59 ISO 10993-18 in the MDR: understanding the restrictions & risk assessment for different compounds 27:57 What Manufacturers Need to Know about the Updated ISO 10993-1 and New ISO 21726 56:41 After E&L: Updates to the Standard for Toxicological Risk Assessment 10993-17 29:39 Changes to ISO10993-1 and relationship to Medical Device Regulation 1:02:35 Updates & Trends from FDA; Including Recent ISO 10993 News 17:36 ISO 10993-18 - Introduction to Extractables and Leachables testing for medical devices 1:01:11 Shifting Requirements Within the FDA: Expectations in Chemistry Study Design 44:54 New Regulatory Changes that Impact Medical Devices: Using Chemistry to Assess Safety 59:49 WEBINAR | Medical Devices: Regulations and Chemical Characterization 1:00:40 WEBINAR | Applying ISO 10993-18 on Extractables & Leachables Characterization 1:01:38 Big Changes to ISO 10993-1, what is happening to the main biocompatibility standard now? 57:28 FDA and ISO stars aligning on ISO 10993 01:46 ISO 10993-18: 2020 Extractable/Leachable Evaluation 1:28:09 Understanding Chemical Characterization and ISO 10993 17 and 10993 18 59:35 Requirements and Impact of the New Guideline - ISO 10993-23: Tests for Irritation 42:21 How the new FDA guidance ‘Use of International Standard ISO 10993-1 affects you 1:01:08 How to Address Regulatory Change in Your Current Biocompatibility Program More results