Design controls for the medical device industry
Abstract
The second edition of a bestseller, Design Controls for the Medical Device Industry provides a comprehensive review of the latest design control requirements, as well as proven tools and techniques to ensure your company's design control program evolves in accordance with current industry practice. The text assists in the development of an effectiv
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Safety-critical and regulated industries such as aerospace and medicine have long traditions of auditable processes and design controls that have dramatically improved safety.
“While not without faults, safety-critical and regulated industries such as aerospace and medicine have long traditions of auditable processes and design controls that have dramatically improved safety [77,81].”
From Closing the AI accountability gap: defining an end-to-end framework for internal algorithmic auditing (2020) · cites this paper as [77]
Cited by
Sorted by citations
Raji, I. D., Smart, A., White, R. N., Mitchell, M., Gebru, T., Hutchinson, B., Smith-Loud, J., Theron, D., & Barnes, P. (2020) · Proceedings of the 2020 Conference on Fairness, Accountability, and Transparency · doi:10.1145/3351095.3372873 · Cited by 1,372 · see citing works
- Authors
- Teixeira, M. B., Teixeira, M., & Bradley, R.
- ORCID
- Bradley, Richard
- Venue
- CRC Press eBooks
- Publisher
- CRC Press
- Published
- 2013-11-12
- OpenAlex
- W4300470088
- Cited by
- 9
- References
- 0
- Citations by year
- 2023: 1 · 2022: 3 · 2019: 1 · 2017: 1 · 2016: 1 · 2014: 1
- FWCI
- 0.58
- Type
- book
- Language
- en
- Open access
- closed
- Locations
- CRC Press eBooks (publishedVersion)
- Topics
- Health Sciences › Health Professions › Health Information Management › Healthcare Regulation
- Health Sciences › Health Professions › Medical Laboratory Technology › Quality and Safety in Healthcare
- Physical Sciences › Engineering › Safety, Risk, Reliability and Quality › Safety Systems Engineering in Autonomy
- Keywords
- design control, medical devices, regulatory compliance, quality management, medical device regulation
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
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