The Importance of the DHF and DMR

DHFs and DMRs are critical to demonstrate compliance throughout the entire product lifecycle. Both types of records are for:

• Documenting dynamic records that continually change (with traceable revision control)
• Submitting regulatory submissions to the FDA and international regulatory bodies
• Preventing nonconformances and product recalls

The DHR and DMR

Design History File (DHF): This is a collection of records that describe the design history of a medical device. The FDA specifies requirements for the DHF in Title 21 CFR section 820.30 as follows.

Each manufacturer shall establish and maintain a DHF for each type of device. The DHF shall 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.

Device Master Record (DMR): The DMR is comprised of drawings, instructions, and other records used to produce a product. According to FDA Title 21 CFR section 820.181, manufacturers shall ensure that each DMR is prepared and approved in accordance with 820.40:

The DMR shall include, or refer to the location of, the following information:

• Device specifications including appropriate drawings, composition, formulation, component specifications, and software specifications;
• Production process specifications including the appropriate equipment specifications, production methods, production procedures, and production environment specifications;
• Quality assurance procedures and specifications including acceptance criteria and the quality assurance equipment to be used;
• Packaging and labeling specifications, including methods and processes used; and
• Installation, maintenance, and servicing procedures and methods.

Design Controls

To demonstrate compliance and proper design controls, companies must be able to effectively manage the DMR and DHF in context with each other and the entire product record. To manage the entire product record, you must have the ability to manage a complete bill of materials (BOM) for electrical, mechanical, and software parts.

When medical device companies are audited by the FDA, they may be subject to any of the following actions if they fail to comply with any quality system regulations including DMR and DHF management:

• Increased audit schedules
• Failure to approve new products
• 483 Observations
• Warning letters
• Product recalls
• Plant closing
• Civil penalties, fines, and even jail time in extreme cases