Medical device manufacturers use cytotoxicity testing to help prove that devices that come into contact with the human body are biocompatible. Testing results are critical for gaining market access, ...

The accreditation allows EXALTA to perform microbiology testing in-house rather than relying on external partners.

The US Food and Drug Administration (FDA) has cited a medical device manufacturer and a contract drug testing laboratory for violations of current good manufacturing practices (CGMP). Additionally, ...

PISCATAWAY, N.J.--(BUSINESS WIRE)--The first medical devices from companies including Ascensia have been certified under the new IEEE Medical Device Cybersecurity Certification Program. Test ...

Advanced biologics and patient-specific therapies reduce opportunities for terminal sterilization, elevating proactive microbial risk control and integrating QC microbiology into CCS authorship, risk ...

In a session on the impact of IVDR on molecular testing, presenters noted a lack of clarity and flexibility while endorsing new amendments.

A new study has demonstrated rapid and sensitive on-site detection of SARS-CoV-2 RNA from environmental surfaces using a portable laboratory device. The study was published in Microbiology Spectrum, a ...