Design Change Impact on Biocompatibility and Documentation
Change management in the design of medical devices is a critical process, frequently highlighted in FDA 483...
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On Site Inspections: They’re Back – But When, Where and How
With the development and distribution of COVID-19 vaccines, the global health crisis is beginning to ease in...
Cleaning, Disinfection and Sterilization of Medical Devices: Updates to Reprocessing Guidance Documents AAMI TIR 12 and TIR30 (ST98)
The cleaning, disinfection, and sterilization of medical devices are critical processes that ensure patient safety and device...
After E&L Updates to the Standard for Toxicological Risk Assessment 10993-17
The use of extractables and leachables (E&L) chemistry testing has become integral and often essential in the...
Cytotoxic Reactivity Understanding the Cause and the Path Forward
All medical devices intended to contact patients must undergo a rigorous biological evaluation to ensure their safety....
Best Practices for Investigating Quality Deviations
The COVID-19 pandemic has led to a significant backlog of delayed inspections, and the FDA is now...
LVP Polyolefin Solutions Addressing Different Packaging and Regulatory Requirements
Large Volume Parenterals (LVPs) can be packaged in a variety of formats made from polyolefins, including pouches,...
Preparing for FDA Remote Inspections
Stay ahead of the curve by learning from experts about virtual inspection training, preparing you for next...
Applying a Risk Based Approach to Biological Evaluation of Medical Devices Based on the ISO 10993:18
All medical devices that are intended to contact patients or medical personnel (directly or indirectly) require an...
Primary and Secondary Packaging Materials as Potential Source of Nitrosamines
Recently, several drug product recalls have occurred due to the unexpected presence of N-Nitrosamines. While the formation...