Med-Tech Innovation Regulation
Meeting Regulatory Requirements:
THE DESIGN HISTORY FILE
W
herever you are in the product development cycle, being aware of the requirements can ease the headache of compliance later on. European regulatory
authorities require a documented design history. The Design History File (DHF) should contain the following information: a) A description of the DHF (for example, that it is a file of quality documents related to a certain device design) and the names of the types of documents that it will contain. The DHF must describe the complete history of the design of a particular device or component assembly of a device. It should address the development of the device, accessories, major components, labelling, packaging and the manufacturing process.
Even though every step in the design phase of the device may not be documented, the whole design history should be apparent from the contents of the DHF. The DHF must reference or contain enough records to prove that the design was developed in accordance with a design and development plan and other regulatory and design control requirements, as detailed below in point (b). The final design output from the design phase should be present in the DHF as filed documents or by reference.
The documents in the DHF serve as the basis for the device master record. If a company has more than one device design under development, more than one DHF will need to be prepared. Each device family needs its own DHF. If similar devices are simple variants of a single familial design, then a single DHF may be warranted. Each distinct design type should have its own DHF.
b) The DHF should contain the design and development plan, results of design reviews, design validation and verification results and any other data needed to show compliance with design requirements. It should also contain or reference all of the documents that will demonstrate compliance with the design plan. The design control procedures should also be included in the DHF. These procedures describe the process by which the device design is changed ensuring that all changes are reviewed, authorised and tested as necessary before going live. Review includes
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items such as risk management, biocompatibility, effects on sterilisation, shelf life, functionality and the like.
c) The DHF serves as a long term memory for the company so that successive generations of workers may understand the history of how the device was developed, what decisions were made and for what reason. It will contain the verification and validation studies and also the safety and failure mode studies that may be referenced in the event that problems develop. The file should be named for the design that it will contain and also be labelled with any product or design codes for the device.
Read the online version of this article for some useful definitions at
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Design and development process
Chris Shenton is Medical Device Regulatory Specialist at High Edge Consulting BioCity Nottingham Pennyfoot Street Nottingham NG1 1GF, UK tel. +44 (0)115 9216 200, e-mail:
info@highedge.co.uk www.highedge.co.uk
November/December 2011 ¦ 37
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