FCPA Compliance Report-Episode 346, Mike Skopets on Miller’s Summer 2017 FCPA Report
After a long wait, the U.S. Food and Drug Administration (FDA) recently published a Final Rule to harmonize the Quality System Regulation (QSR) codified at 21 C.F.R. Part 820 with the internationally accepted standard for...more
The US Food and Drug Administration (FDA) published its Medical Devices; Quality System Regulation Amendments proposed rule to amend the medical device Quality System Regulation (QSR) on February 23, 2022. While FDA generally...more
The International Electrotechnical Commission (IEC) and the International Organization for Standards (ISO) recently published a cybersecurity standard that has received limited press but may have a significant impact on...more