FDA Regulated Quality Electronic Records and Signatures: Supporting Compliance with 21 CFR Part 11 12 months ago The FDA published CFR Part 11, sometimes referred to as Title 21 CFR Part 11, in 1997, specifies the standards… Medical Device Compliance 101 4 years ago The Medical Device Amendments of 1976 regulates consumer access to new and improved devices, while keeping unsafe or ineffective ones…