Quality management and US regulatory auditing guidelines for medical device manufacturers-Reference-Cited by-同舟云学术

Quality management and US regulatory auditing guidelines for medical device manufacturers

Published:2021-05-21 Issue:4 Volume:11 Page:733-744
ISSN:2190-7188
Container-title:Health and Technology
language:en
Short-container-title:Health Technol.

Author:

Mishra Sunaina^ORCID,Shukla Vikesh Kumar

Publisher

Springer Science and Business Media LLC

Subject

Biomedical Engineering,Applied Microbiology and Biotechnology,Bioengineering,Biotechnology

Link

https://link.springer.com/content/pdf/10.1007/s12553-021-00566-2.pdf

Reference35 articles.

1. Kruger KH, Kruger MA. The Medical Device Sector. In: Burns LR, editor. The Business of Healthcare Innovation. Cambridge: Cambridge University Press; 2020. p. 321–97.

2. International medical device regulators forum. Guidelines for Regulatory Auditing of Quality Systems of Medical Device Manufacturers – Part 1: General Requirements. http://www.imdrf.org/docs/ghtf/final/sg4/technical-docs/ghtf-sg4-99-28-guidelines-auditing-device-manufacturer-quality-systems-part-one-990629.pdf.

3. Food and Drug Administration. Medical Device Overview. https://www.fda.gov/industry/regulated-products/medical-device-overview.

4. World Health Organization. Medical Device – Full Definition. http://www.who.int/medical_devices/full_deffinition/en/.

5. Blumentritt P. Quality Management. In: Audits for Medical Devices. Seleon. 2018. https://www.regulatory-affairs.org/en/quality-management/news-page/audits-for-medical-devices/. Accessed 12 Sept 2020

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