Chemical Disinfection Validations for Reusable Devices
Chemical disinfection validations for reusable devices are critical to ensure the safety and efficacy of medical devices...
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Why Extractables and Leachables Matter
Medicines and other healthcare products rely on a delicate balance between quality, safety, and efficacy for their...
When Drug Meets Device
When a medicinal product (drug or biologic) meets a medical device, a combined product is created. Incompatibility...
Use of Exaggerated Surface Area to Solution Volume Ratios in Extractables Studies; Equilibrium Case
The goal of this whitepaper is to provide comprehensive guidance and justify appropriate practices concerning the proper...
Use of Accelerated Conditions in Extractables and/or Leachables Studies
The purpose of this whitepaper is to delve into the scientific principles behind establishing accelerated contact conditions...
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...
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...