Our goal through these challenging times is to provide educational updates and continue evolving our partnership through additional services. We are in this together.
For textile devices that make antimicrobial claims, the U.S. FDA requires manufacturers to provide proof of a certain level of antimicrobial efficacy.
Labs ask a lot of questions to be able to develop a solid test plan and accurate quote. Here are 5 things you need to tell your lab at the outset.
Working with an experienced lab testing partner that is well-versed in the latest standards can save you time, money and manpower – here’s how to vet them.
We’re letting you in on the secret to having success in the lab, and our obsession with finding answers.
New identification standards are putting pressure on manufacturers’ submissions. Make sure your sensitivity is up to regulations.
A risk-based approach that tailors test requirements to the specific risks of each device.
Not only are we your testing partner, we also have international regulatory experience. We can very quickly see trends and adapt to those changes as they come.
Senior Director, Analytical Chemistry and Regulatory Toxicology
Unknowns are Unacceptable
Mitigating the Impact of an FDA Warning Letter