Medical Products Standards

Ultimate List of ISO Standards for Medical Devices

https://www.greenlight.guru/blog/iso-standards

Oct 5, 2022

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 …

Standards and Conformity Assessment Program | FDA

https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/standards-and-conformity-assessment-program

Recognition is the process whereby the FDA identifies standards to which manufacturers of medical devices may submit a declaration of conformity to demonstrate …

What Standards Apply to Medical Devices …

https://www.nqa.com/en-us/certification/sectors/medical-devices-services

For medical device manufacturers, ISO 9001 engages management in the quality control process, helping make organization-wide changes that keep costs down, improve …

Quality System (QS) Regulation/Medical Device Good …

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

ISO - New ISO standards for medical devices

https://www.iso.org/news/ref2534.html

ISO 20417, Medical devices – Information to be supplied by the manufacturer, simplifies the process of meeting product information regulations by providing common …

Health products policy and standards - World Health …

https://www.who.int/teams/health-product-policy-and-standards/standards-and-specifications

The international standards established by the Committees are public standards that facilitate and stimulate production and registration of medicines, are the basis for the …

Health products policy and standards - World Health …

https://www.who.int/teams/health-product-policy-and-standards/assistive-and-medical-technology/medical-devices/regulations

The 67th WHA approved the resolution “Regulatory system strengthening for medical products." It states the importance of regulations for medical devices as one of the …

Healthcare - Standards - Occupational …

https://www.osha.gov/healthcare/standards

OSHA maintains a listing of the most frequently cited standards for specified 6-digit North American Industry Classification System (NAICS) codes. Please refer to …

Medical Device Standards: Purpose And …

https://www.scnsoft.com/blog/medical-device-standards

ISO 14971:2019 describes terminology, principles, and a process for risk management of medical devices, software as a medical device, and in vitro …