FDA QSR UPDATE – ISO 13485 Alligned QMSR Final Rule Getting Closer

By Eric Thorn, Esq Beginning back in the spring of 2018, FDA announced its intent to adopt rules to replace the current quality system regulations (QSR) found in 21 CFR Part 820 with rules more aligned with International Organization for Standardization (“ISO”) standard ISO 13485:2016 (ISO 13485). This year, on February 23, 2022, FDA published…

Standards Matter – Why it is Important to Work With a CDT, CDL or DAMAS Laboratory

STANDARDS MATTER Why it is Important to Work with a CDT, CDL or DAMAS Laboratory By: Heather Voss, CDT Whenever we drive a car, purchase something online, use a cellphone or take our children to an amusement park, we are benefiting from minimum quality standards without even knowing it.  Standards have become such an integral…