Medical Device Quality System Regulation

Quality System (QS) Regulation/Medical Device Good …

https://www.fda.gov/medical-devices/postmarket-requirements-devices/quality-system-qs-regulationmedical-device-good-manufacturing-practices

Quality and Compliance (Medical Devices) | FDA

https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/quality-and-compliance-medical-devices

The FDA also recognizes that proper maintenance, repair, and servicing of medical devices is critical to maintaining the safe, effective, and reliable performance of devices used in …

Proposed Rule: Quality System Regulation Amendments …

https://www.fda.gov/medical-devices/quality-system-qs-regulationmedical-device-good-manufacturing-practices/proposed-rule-quality-system-regulation-amendments-frequently-asked-questions

On February 23, 2022, the FDA issued a proposed rule to amend the device current good manufacturing practice (CGMP) requirements of the Quality System (QS) …

eCFR :: 21 CFR Part 820 -- Quality System Regulation

https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-820

(t) Quality audit means a systematic, independent examination of a manufacturer's quality system that is performed at defined intervals and at sufficient frequency to determine …

Quality System Regulations | FDA

https://www.fda.gov/science-research/clinical-trials-and-human-subject-protection/quality-system-regulations

The quality system regulation includes requirements related to the methods used in, and the facilities and controls used for, designing, manufacturing, packaging, labeling, storing,...

Medical Devices; Quality System Regulation Amendments

https://www.federalregister.gov/documents/2022/02/23/2022-03227/medical-devices-quality-system-regulation-amendments

The Food and Drug Administration (FDA, the Agency, or we) is proposing to amend the device current good manufacturing practice (CGMP) requirements of the …

Quality Systems | FDA - U.S. Food and Drug Administration

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-guides/quality-systems

Code of Federal Regulations, Title 21 (21 CFR) Part 820 Quality System Regulation; Part 803 Medical Device Reporting; Part 806 Medical Device Corrections and Removals; Part 821...

Quality System Regulation Labeling Requirements | FDA

https://www.fda.gov/medical-devices/device-labeling/quality-system-regulation-labeling-requirements

Sterile Device Labeling Contract Sterilization Introduction Medical device manufacturers must incorporate in their quality assurance (QA) program several elements that relate to …

eCFR :: 21 CFR Chapter I Subchapter H -- Medical Devices

https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H

eCFR :: 21 CFR Chapter I Subchapter H -- Medical Devices eCFR The Electronic Code of Federal Regulations Title 21 Displaying title 21, up to date as of 2/08/2023. Title 21 was …

ISO - ISO 13485:2016 - Medical devices — Quality …

https://www.iso.org/standard/59752.html

ISO - ISO 13485:2016 - Medical devices — Quality management systems — Requirements for regulatory purposes ISO 13485:2016 Medical devices — Quality management systems — Requirements for regulatory …