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...
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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...
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,...
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...
Sterilization Dose Audits – The “Why” and the “How”
In the medical device industry, sterilization processing is performed to obtain a Sterility Assurance Level (SAL) as...
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...
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...