October 12, 2000
“Your firm failed to adequately validate software integral to the IVD, IVD wireless and … devices as required by 21 CFR 820.75. For example, structural testing of the software is not completed or documented, there are no software validation protocols available, and the compilers were not validated (FDA 483, Item #5).” SoftwareCPR keywords: Product software,...
Read More

What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:

Corporate Office

15148 Springview St
Tampa, FL 33624
Partners located in the US (CA, FL, MA, MN) and Italy.