The new cleanroom at our global headquarters in Salt Lake City, Utah, was designed for today's rigorous contamination control expectations, driven by EU GMP Annex 1. Learn More
Cleaning is an essential step to ensure the safe processing of reusable medical devices. In recent years, national and international standards and guidelines have matured to define scientifically sound analytical requirements to define endpoints for cleaning. Although these requirements can...
An ever-evolving regulatory landscape, combined with increasingly complex and diverse medical devices, has challenged the testing protocols for many medical device manufacturers (MDMs). More companies want improved validation and accreditation processes, especially for pre-clinical device safety testing. Validation of cleaning,...
Medical devices couldn’t exist without safe and effective packaging. Many types of containers—pouches, clamshell packs, blister packs, and others—protect marketed devices from contamination, whether their end-users are clinicians or consumers. Devices are often packaged in materials that can be as...
To try to stem the increasing incidences of healthcare-associated infections (HAIs), hospitals are stepping up their disinfecting protocols on medical devices. But these more-stringent practices that may use either stronger chemicals, or the more frequent use of them, or maybe...
Medtech companies have been working for a couple years to update their approach to biocompatibility testing in preparation for the new ISO 10993-1, “Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process,” which became...
