Design history file


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

Requirements

The 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].

Design controls

Each 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.

See also

References

  1. ^ a b Harnack, Gordon (1999). Mastering and Managing the FDA Maze: Medical Device Overview. American Society for Qualit. ISBN 9780873894555. 
  2. ^ Device Inspections Guide. Washington Business Information. p. 52657. ISBN 9781932074109. 

External links


Wikimedia Foundation. 2010.

Look at other dictionaries:

  • Design management — is the business side of design. Design managers need to speak the language of the business and the language of design …   Wikipedia

  • History of clothing and textiles — Ladies making silk, early 12th century painting by Emperor Huizong of Song (a remake of an 8th century original by artist Zhang Xuan), illustrates silk fabric manufacture in China. The wearing of clothing is exclusively a human characteristic and …   Wikipedia

  • Design Web Format — Filename extension .dwf, .dwfx Developed by Autodesk Type of format CAD Design Web Format (DWF) is a secure file format developed by Autodesk for the efficient distribution and communication of rich design data to anyone who needs to view, review …   Wikipedia

  • History of Canada — This article is part of a series Timeline …   Wikipedia

  • Design and Arts Arcadia of Myungseung — Founded 2004 Founder(s) Soon Jo Lee, CEO Headquarters Seoul, Korea …   Wikipedia

  • History of the National Hockey League — History of the NHL National Hockey League Founding (1917–1942) Original Six (1942–1967) …   Wikipedia

  • File Allocation Table — For other uses, see Fat (disambiguation). FAT Developer Microsoft Full Name File Allocation Table FAT12 (12‑bit version) FAT16/FAT16B (16‑bit versions) FAT32 (32‑bit version with 28 bits used) Introduced …   Wikipedia

  • History of virtual learning environments 1990s — In the history of virtual learning environments, the 1990s was a time of growth, primarily due to advent of the affordable computer and of the Internet.1990s1990* Formal Systems Inc. of Princeton, NJ, USA introduces a DOS based Assessment… …   Wikipedia

  • History of virtual learning environments — A virtual learning environment (VLE) is a system that creates an environment designed to facilitate teachers in the management of educational courses for their students, especially a system using computer hardware and software, which involves… …   Wikipedia

  • History of the Internet — Main article: Internet The history of the Internet starts in the 1950s and 1960s with the development of computers. This began with point to point communication between mainframe computers and terminals, expanded to point to point connections… …   Wikipedia


We are using cookies for the best presentation of our site. Continuing to use this site, you agree with this.