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发帖数: 1652 | 1 http://en.wikipedia.org/wiki/Design_history_file
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.[1] Prior to this legislation, U.S. Food and Drug
Administration (FDA) auditors were limited to examining the production and
quality control records of the device.
Contents [hide]
1 Requirements
2 Design controls
3 See also
4 References
5 External links
[edit] RequirementsThe regulation requires of medical devices manufacturers
of Class II and Class III devices to implement design controls. These design
controls consist of a development and control plan used to manage the
development of a new product, and a design history file where these
activities are documented. These controls are specifically intended to
manage a medical device company's new product development activities.
Research and development processes aimed at developing new underlying
technologies are not subject to these regulations. The requirements for a
DHF are documented in FDA Regulation CFR 21 820.[1].
[edit] Design controlsEach manufacturer of either a class II or class III
medical device (as well as a select group of class I devices) needs to
establish and document procedures on the design and design requirements.
These design controls include:[2]
Design input - Design inputs are typically the initial requirements that
describe the medical device to be produced.
Design output - Design outputs are the results of the design and engineering
efforts. These are normally the final specifications for the device.
Including the manufacturing process and the in-coming, in-process and
finished device inspection, measurement or test methods and criteria. The
outputs are normally documented in models, drawings, engineering analysis
and other documents. The output needs to be directly traceable to the input
requirements. Design verification and validation should demonstrate that the
final output specifications conform to the input requirements and meet user
needs and intended uses.
Design review - The design review is a formal review of the medical device
design by representatives of each design function participating in the
design efforts as well as other interested parties (e.g. marketing, sales,
manufacturing engineering, etc.). The design review must be documented in
the DHF and include review date, participants, design version/revision
reviewed and review results.
Design verification - Design verification is the process that confirms that
the design output conforms to the design input. Design verification should
demonstrate that the specifications are the correct specifications for the
design. Design verification must be documented in the DHF and include the
verification date, participants, design version/revision verified,
verification method and verification results.
Design validation - Design validation is the process in which the device
design is validated using initial/low volume production processes. The
purpose for the design validation is to confirm that the design functions
according to design inputs when produced using normal production processes
rather than prototype processes. The design validation must be documented in
the DHF.
Design transfer - Design transfer is the process in which the device design
is translated into production, distribution, and installation specifications.
Design changes - Design changes is the process in which the design changes
are identified and documented. Also known as engineering change or
enterprise change.
Design history file - The DHF is a formal document that is prepared for each
medical device. The DHF can be either a collection of the actual documents
generated in the product development (PD) process or an index of documents
and their storage location. |
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