FDA Regulated

Quality Electronic Records and Signatures: Supporting Compliance with 21 CFR Part 11

Quality Electronic Records and Signatures: Supporting Compliance with 21 CFR Part 11

The FDA published CFR Part 11, sometimes referred to as Title 21 CFR Part 11, in 1997, specifies the standards…

Medical Device Compliance 101

The Medical Device Amendments of 1976 regulates consumer access to new and improved devices, while keeping unsafe or ineffective ones…