September 17, 2019
This roundtable discussion examines the technological and regulatory factors affecting the third-party testing and analysis services industry. Medical and orthopedic devices are becoming smaller and more complex. Manufacturing technologies are advancing, new materials are frequently being created, and regulations are...
See BlogSeptember 1, 2019
The industry currently is lacking sufficient guidance from regulatory bodies regarding the disinfection requirements for non-patient-contacting, noncritical medical devices or equipment. A more practical disinfection level is needed – one that represents the actual use and probable contamination of these...
See BlogAugust 1, 2019
There are many options available for Container Closure Integrity (CCI) testing of glass vials and syringes. From traditional probabilistic methods like Dye Immersion (tracer dye) or Bacterial or Microbial Challenge testing, to a variety of deterministic methods like Vacuum Leak,...
See BlogJune 26, 2019
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...
See BlogMarch 7, 2019
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,...
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