Packaging Trends Leading to Increased 483’s
In this presentation, we will explore recent packaging trends in the medical device industry, particularly those highlighted...
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Coronavirus & Barrier Material Tests
According to the CDC and OSHA, the minimum recommended protection against possible contact with the coronavirus is...
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...
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...
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,...
Selecting & Justifying Sample Sizes: Where to Begin?
Within the medical device industry, determining the ideal sample size is crucial for ensuring accurate testing and...
Single Use & Newly Manufactured Device Cleaning Validations
Performing a cleaning validation during the initial phase of a device’s lifecycle is crucial for manufacturers to...
Successful Medical Device Cleaning Validations: What You Need to Know
Validating cleaning instructions for a tray of reusable orthopedic devices is an essential milestone on the path...
The Use and Utility of General Chemistry Data in Extractables Assessment
This whitepaper explores the critical role of general chemistry data obtained in controlled extraction studies, including pH,...
Understanding the EU Medical Device Regulation for Device Companies
The new European Union (EU) Medical Device Regulation (MDR), effective from May 2020, will significantly impact medical...