What Really Changed: A Look at the Updated FDA Guidance Document for ISO 10993-1 Published 2023-12-06 Download video MP4 360p Download video MP4 720p Recommendations 48:05 Package Validations – Meeting the Requirements of ISO 11607 1:06:00 Packaging related nitrosamines in Drug Products 28:23 FDA Product Regulations Part 1 of 7 36:44 Biocompatibility as a Critical Design Input 3:24:58 Agile Scrum Full Course In 4 Hours | Agile Scrum Master Training | Agile Training Video |Simplilearn 29:25 Medical Device Chemical Characterization 59:52 MIT 6.S191 (2023): Deep Generative Modeling 12:49 Intermittent Fasting’s Darkest Secret 15:51 How to listen like a therapist: 4 secret skills 1:03:44 What’s New with Reprocessing Validations for Reusable Medical Devices 31:54 GMP 101 - Intro to Good Manufacturing Practice [WEBINAR] 1:28:37 FDA Cybersecurity and Software Policy Updates: Navigating the New FDA Guidance Documents for MedTech 38:27 Meeting New Challenges in Toxicological Risk Assessment: Pending Updates to ISO 10993-17 1:01:43 What the FDA's Final Rule Means for the Future of Laboratory Developed Tests 48:01 Container Closure Requirements: Preparing for USP 382, 661.1, & 661.2 57:33 MIT 6.S191 (2023): Reinforcement Learning 1:00:09 Advancing Microbial-Contamination Detection Through Rapid Sterility Testing 46:41 What Makes a Successful ISO 18562 Toxicological Risk Assessment? 25:43 How to design an Instruction For Use and validations for EU and US 44:52 Nitrosamine Impurities-Aug 2023 NDSRIs Limit USFDA Guidance | Control of Nitrosamine Guidance Feb-21 Similar videos 42:21 How the new FDA guidance ‘Use of International Standard ISO 10993-1 affects you 34:15 MDM West Tech Theater: New FDA Guidance on ISO 10993-1 and How it Affects You 1:03:17 How the New FDA Guidance on ISO 10993 Could Possibly Affect You 1:02:35 Updates & Trends from FDA; Including Recent ISO 10993 News 1:01:38 Big Changes to ISO 10993-1, what is happening to the main biocompatibility standard now? 31:36 The Current State of Biocompatibility: How FDA & CE Are Looking at Biocompatibility 1:00:26 Assessing Biocompatibility for Medical Devices: Updates, Trends, and Anticipated Changes 1:00:54 What is Changing in the Global Reglatory Landscape 43:06 Summarize all your findings in a Biological Evaluation Report (BER) 32:05 How the New FDA Guidance on ISO 10993 Could Affect You from BIOMEDevice San Jose 2014 1:01:08 How to Address Regulatory Change in Your Current Biocompatibility Program 17:37 FDA Trends Impacting Hemocompatibility & Genotoxicity Testing including an ISO 10993 Update 39:01 Biocompatibility Standard Changes: Is Your Testing Up to Date? 59:59 Developing a Biological Safety Evaluation 45:38 Biocompatibility: Applying the New ISO 10993 Standards 1:01:13 Develop a Biological Evaluation Plan (BEP) 43:06 Day 3: Summarize all your findings in a Biological Evaluation Report BER 56:57 The Big Three: Cytotoxicity, Sensitization & Irritation Testing More results