DAY 1 – Big Changes in Medical Device Biocompatibility: Updates Coming to ISO 10993-1
This three-day webinar series explores major changes coming to medical device biocompatibility standards. Day 1 covers critical updates...
Browse Content
DAY 2 – Big Changes in Medical Device Biocompatibility: Updates to USP Class VI Impacting Medical Device Materials
This three-day webinar series explores major changes coming to medical device biocompatibility standards. Day 1 covers critical updates...
DAY 3 – Big Changes in Medical Device Biocompatibility: How to Address These Updates for Existing Products and In-Process Submissions
This three-day webinar series explores major changes coming to medical device biocompatibility standards. Day 1 covers critical updates...
Updates to ISO 10993-1: Focus on Foreseeable Misuse
There are many updates to ISO 10993-1 a few of which can significantly impact how devices are...
ISO 10993-1: Key update on the new revision of this critical standard
This webinar delves into the latest updates to ISO 10993-1, the cornerstone standard guiding biocompatibility assessment for...
Documenting Device Changes in Biological Risk Assessments: Part Three
This is the third whitepaper in a four-part series covering different examples of how to document device...
Documenting Device Changes in Biological Risk Assessments: Part Two
This whitepaper, the second in a four-part series covering different examples of device changes to be documented...
Transitioning From Cell-Based Assays to qPCR-Driven Analyses To Ensure Viral Safety in Biologics Manufacturing
The production of biological products in biopharmaceutical manufacturing involves significant risks of viral contamination from human and...
Testing of High-Risk Drug Components for Diethylene Glycol and Ethylene Glycol
Contamination from ethylene glycol and diethylene glycol in liquid formulation poses a high risk to patient safety....
Documenting Device Changes in Biological Risk Assessments: Part One
“Device changes can range in complexity, making it critical that each change be treated uniquely and assessed...