Microtest Laboratories has issued a management brief that discusses reusable medical device cleaning validation and testing practices in view of the FDA’s own discussions and actions around ...

The US Food and Drug Administration (FDA) has cited a medical device manufacturer and a contract drug testing laboratory for ...

Medical device equipment manufacturers work in an environment where product quality isn't just a competitive advantage, it's a regulatory necessity with direct implications for patient safety. As ...

In the medical device industry, usability plays a critical role in ensuring the safety and effectiveness of highly complex medical products. The IEC 62366-1:2015 standard, which focuses on the ...