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Design review; Design transfer ensuring that the device design is correctly translated into production specifications; Design changes; Design history file, a demonstration that the design was developed according to the approved design plan and 21 CFR 820.30.
The US Food and Drug Administration requires that developers of medical device follow a system of design controls.A key part of this system is design review, defined in 21CFR820.3 section (h) as "a documented, comprehensive, systematic examination of the design to evaluate the adequacy of the design requirements, to evaluate the capability of the design to meet these requirements, and to ...
To comply with the United States Food and Drug Administration's code FDA 21 CFR 820.100 [5] medical device companies need to establish a CAPA process [6] within their QMS. . This part of the system may be paper or digital, but it is something that is looked for during an FDA visi
The rule is promulgated at 21 CFR 820. [ 5 ] According to current Good Manufacturing Practice (GMP), medical device manufacturers have the responsibility to use good judgment when developing their quality system and apply those sections of the FDA Quality System (QS) Regulation that are applicable to their specific products and operations, in ...
A design history file is a compilation of documentation that describes the design history of a finished medical device.The design history file, or DHF, is part of regulation introduced in 1990 when the U.S. Congress passed the Safe Medical Devices Act, which established new standards for medical devices that can cause or contribute to the death, serious illness, or injury of a patient.
The following contents are listed in the relevant chapter of the CFR [1] as part of the Device Master Record: (a) Device specifications including appropriate drawings, composition, formulation, component specifications, and software specifications;
Quality audits can be an integral part of compliance or regulatory requirements. One example is the US Food and Drug Administration, which requires quality auditing to be performed as part of its Quality System Regulation (QSR) for medical devices (Title 21 of the US Code of Federal Regulations part 820 [2]).
Custom devices are subject to requirements including labelling (21 CFR Part 801), reporting (21 CFR Part 803), corrections and removals (21 CFR Part 806), registration and listing (21 CFR Part 807) and quality systems regulation (21 CFR 820).