Implementing Risk Managed Supplier Quality
A risk-managed approach to the global supply chain is more important than ever for life science manufacturers....
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Internal Audit Be Ready for FDA Inspections Hope is not a Strategy
Life science companies recognize that the FDA inspection process is a cornerstone of ensuring the safety and...
IVDR Regulation for Medical Device Directive in EU: Impact Assessment of Revision of the Regulatory Framework for MDD in EU
The existing regulatory framework for medical devices, which has been in place for 20 years, has recently...
Three Methods to Establish the Sterilization Dose of a Medical Device
In the medical device industry, sterilization processing is performed to obtain a Sterility Assurance Level (SAL) as...
US Food and Drug Administration Regulatory Pathways
Over the past five years, the medical device industry has witnessed an explosion of new and innovative...
Selecting & Justifying Sample Sizes: Where to Begin?
Within the medical device industry, determining the ideal sample size is crucial for ensuring accurate testing and...
Rapid Sterility Testing: A New Solution For Short Shelf Life Products
All drug products must undergo sterility testing to comply with Good Manufacturing Practices (GMP). Parenteral drug products,...
Material Consideration Radiation Processing
Each polymer reacts differently to ionizing radiation, making it crucial to verify that the maximum administered dose...
How Chemical Characterization Can Supplement and Support Biocompatibility Testing
There’s a lot of urban legend when it comes to using gamma radiation to reduce pathogens in...
Establishing the Proper Alcohol/Water Proportion for Simulating Solvents Used in Controlled Extraction Studies
The purpose of this whitepaper is to provide comprehensive guidance on determining the appropriate alcohol/water proportion for...
