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Software-Related Recalls of Health Information …
- https://pubmed.ncbi.nlm.nih.gov/28895231/
- Provisions of the 21st Century Cures Act that became law in late 2016 will reduce safeguards further. Absent stronger regulations and implementation to create robust risk assessment and adverse event reporting, physicians and their patients are likely to be at …
Software-related recalls: an analysis of records - PubMed
- https://pubmed.ncbi.nlm.nih.gov/24328977/
- In the analysis of recalls reported from 2005 through 2011, 19.4% of medical device recalls are related to software. This paper includes analysis results, challenges faced …
An Analysis of Software-Related Recalls of Medical Devices
- https://journals.lww.com/jcejournal/Abstract/2010/07000/An_Analysis_of_Software_Related_Recalls_of_Medical.18.aspx
- Medical device recalls for software-related issues for 2009 were collected from the Food and Drug Administration database and analyzed. The recalls were analyzed by …
Study of Software-Related Causes in the FDA Medical …
- https://ieeexplore.ieee.org/document/8292803
- As technology advances, medical devices are playing increasingly more important roles in patient care. Unfortunately, based on the U.S. Food and Drug …
An Analysis of Software-Related Recalls of Medical …
- https://www.researchgate.net/publication/232157732_An_Analysis_of_Software-Related_Recalls_of_Medical_Devices
- Public and internal databases were examined to evaluate software-related recalls in the medical device industry sector. In the analysis of recalls reported from …
An Analysis of Software-Related Recalls of Medical Devices
- https://www.semanticscholar.org/paper/An-Analysis-of-Software-Related-Recalls-of-Medical-Yang-Hyman/9d1e0cad941375435e10d013e1a1e66e36eef777
- The results indicate the growing importance of software in the domain of medical devices and in medical device problems and some suggestions for both device companies and …
Software-Related Recalls: An Analysis of Records
- https://meridian.allenpress.com/bit/article/47/6/514/142716/Software-Related-Recalls-An-Analysis-of-Records
- In the analysis of recalls reported from 2005 through 2011, 19.4% of medical device recalls are related to software. This paper includes analysis results, challenges …
118. An Analysis of Medical Device Recalls
- https://www.boisestate.edu/undergraduate-research/2020/04/22/118-an-analysis-of-medical-device-recalls/
- An Analysis of Medical Device Recalls. April 22, 2020 ... Data was collected from the FDA Medical Device Recall Database from January 2010-March 2020 by entering “software” and “hardware” …
Failure Modes in Medical Device Software: An …
- https://tsapps.nist.gov/publication/get_pdf.cfm?pub_id=917180
- software recalls. The total number of software recalls from 1983-1997 is 383. The years 1994, 1995, 1996 have 11%, 10%, and 9% of the software recalls. One possibility for this …
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