Uncategorized Archives - ISO13485 Clarity

MEDICAL DEVICE STANDARDS – FDA Guidance

FDA Guidance Docs are topic-specific and should be read and evaluated for applicability. Generally, companies should consider Guidance docs to have same force as Sec 820 regulations. The FDA normally publishes Guidance to clarify issues in CFR, or to provide updated material. FDA archives Guidance docs on their website, but companies should keep important guidance items [...]

MEDICAL DEVICE STANDARDS – FDA GuidanceSuper Admin2020-05-09T18:18:02+00:00

MEDICAL DEVICE STANDARDS – FDA Regulations

These are statutory laws published in the Code of Federal Regulations, CFR. Primarily documented in Sec 820, they create the legal foundation for compliance. Company management should be familiar the scope and content of this material. They are also the foundation of ISO 13485.

MEDICAL DEVICE STANDARDS – FDA RegulationsSuper Admin2020-05-09T18:16:58+00:00

Careless Handling of PHI Violates Patient Privacy

May 2017-----The U.S. Department of Health & Human Services(HHS), Office for Civil Rights (OCR), has announced a Health Insurance Portability and Accountability Act of 1996 (HIPAA) settlement based on impermissible disclosure of protected health information (PHI). St. Luke’s-Roosevelt Hospital Center Inc. (St. Luke’s) has paid HHS $387,200 to settle potential violations of the HIPAA Privacy [...]

Careless Handling of PHI Violates Patient Privacydavid2017-06-15T14:08:04+00:00