Post-market Surveillance (PMS) of Medical Devices: From a Clinical Engineering Perspective

Author:

Judd Thomas

Publisher

Springer Nature Switzerland

Reference33 articles.

1. Badnjević A, Pokvić LG, Džemić Z et al (2020) Risks of emergency use authorizations for medical products during outbreak situations: a COVID-19 case study. BioMed Eng OnLine 19:75

2. Global Harmonization Task Force (2008) Summary technical documentation for demonstrating conformity to the essential principles of safety and performance of medical devices (STED). https://www.imdrf.org/sites/default/files/docs/ghtf/archived/SG1/technical-docs/ghtf-sg1-n011-2008-principles-safety-performance-medical-devices-080221.doc

3. BSI Group Americas (2021) Effective post-market surveillance White Paper. https://www.bsigroup.com/en-US/medical-devices/resources/Whitepapers-and-articles/wp18---effective-post-market-surveillance/

4. Castor Inc (2021) Essential guide to post-market clinical follow-up (PMCF) for medical devices. https://www.castoredc.com/whitepaper/pmcf-medical-devices-guide/

5. Badnjević A, Cifrek M, Magjarević R, Džemić Z (eds) (2018) Inspection of medical devices. In: Series in biomedical engineering. Springer, Singapore

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