Design History File

Blog 22 will talk about Design History File (DHF) and subsequent several blogs will talk about several elements of design control of medical device. For example, Design Planning, Design Input, Design Verification and Validation, Design Changes and Design Transfer.

In a layman language, DHF is the collection and compilation of all product development from product idea, inception, design input, design output, risk management, design verification and validation and design changes. Each medical device is different and therefore the DHF may be different.

 It is also important to realize that DHF should also be updated if there are new changes occurred to the device. For example, after the launch of a medical device and tested in a real situation, there might be customers complaints and injuries that prompt the device manufacturer to change the medical device feature so to reduce the customer complaints and injuries. This new change must also be updated into the DHF.

 The following are some examples of documents that should be included in the DHF.

 ·       Design Plan and Record of plan revision, meeting minutes etc.

·       Design Product Requirement like product description, drawing etc.

·       Customer Input and requirement.

·       Design Input Requirements and all records of reviews and approvals.

·       Research, Studies, Calculations, drawings and Analysis supporting the design.

·       Protocols and reports of all design verification and validation.

·       Clinical Protocols and Reports if this is clinical research done on the device.

·       Risk Management Plan, Analysis and Reports.

·       Records of review and approval of design output documents.

·       Agenda and meeting minutes of design reviews.

·       Records of any design changes.

DHF must be updated and preserved until the medical device is no longer in the market. Even tough, the sponsor is not making the device, as long as the product is in the market, a DHF must be preserved.

Reference	Criteria
21 CFR 820.30 (j)	Has the company established and maintained a design history file (DHF) for each type of device?
21 CFR 820.30 (j)	Does the design history file (DHF) contain or reference the records necessary to demonstrate that the design was developed in accordance with the approved design plan and the requirements of this part?

Disclaimer: Although the author had exhaustively researched all sources to ensure the accuracy and completeness of the information contained in this blog, but no warranty and fitness is implied. I assumed no responsibility and implied warranty of any kind for errors, inaccuracies, omission, or any inconsistency herein. No liability is assumed for incidental or consequential damages in connection with the use of the information contained herein. Readers should always use their own judgment and review all related regulatory guidelines. Guidelines can change over time.