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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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...
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...
When Drug Meets Device
When a medicinal product (drug or biologic) meets a medical device, a combined product is created. Incompatibility...
Why Extractables and Leachables Matter
Medicines and other healthcare products rely on a delicate balance between quality, safety, and efficacy for their...
Chemical Disinfection Validations for Reusable Devices
Chemical disinfection validations for reusable devices are critical to ensure the safety and efficacy of medical devices...
Considerations for Third-Party Reprocessing of Single-Use Medical Devices
Reusing single-use devices that have been safely reprocessed by a third-party reprocessor offers significant benefits for healthcare...
EO Residue Levels in Medical Devices: Best Practices for Demonstrating Compliance with ISO 10993-7
Sterilizing medical devices via ethylene oxide (EO) gas is an effective and widely used practice within the...
Medical Device Extractable and Leachables Testing in 2020
The world of physics is grounded in beautiful universal constants that seamlessly integrate into the equations governing...
Good Identification Practices for Organic Extractables and Leachables Via Mass Spectrometry
Ensuring the safety and efficacy of pharmaceutical products requires the accurate identification of organic extractables and leachables....