insights
Design transfer is an integral part of successful medical device production, yet on its face the one-sentence mention of it in 21CFR820.30(C)(h) seems to somewhat diminish its importance:
(h) Design transfer. Each manufacturer shall establish and maintain procedures to ensure that the device design is correctly translated into production specifications.
However, there’s a lot to unpack in that one sentence. Let’s take a closer look at design transfer.
Design transfer falls under the US FDA’s regulation of design controls for all Class II and Class III medical devices and certain Class I devices. 21CFR820.30(C) requirements center around procedures for manufacturers to control device design including inputs, outputs, review, verification, and validation.
In that context, design transfer sounds like a singular, standalone step in a medical device commercialization plan — the act of getting the design into production after everything else checks out.
While it’s true that design transfer is meant to ensure final product conformance and ultimately smooth production, it doesn’t begin at design handoff to production.
Design History File
Rather, design transfer encompasses all of the required medical device engineering procedures that come before it. The process demonstrates their successful completion by virtue of a Design History File (DHF), which documents the design history and ensures it meets all FDA requirements.
Device Master Record and Device History Record
From the DHF, manufacturing specifications are created and maintained in a Device Master Record (DMR) to guide production. Imagine it like the exact and comprehensive “recipe” to make a medical device. Thus, a DMR is an essential piece in design transfer as it includes:
- Design specifications (drawings, component and software specs, composition, and formulation)
- Equipment, packaging, and labeling specifications
- Equipment installation and maintenance/servicing requirements
- Quality assurance procedures
- Bills of Materials
- Acceptance criteria
Any information related to device manufacturing resides in the DMR. Once production starts, another design transfer activity is necessary. A Device History Record (DHR) is created to capture and maintain all production batch records.
The Design Transfer Checklist
Given all of the information and documentation collected during design transfer, it’s easy to see that the process is far more sophisticated than the brief mention in 21CFR820.30(C)(h) suggests.
Medical device manufacturers must be on top of every aspect of design transfer. There is no one prescribed way to do so, but a favored method is a design transfer checklist.
A design transfer checklist is typically a table with notes and completion checks related to every element of medical device engineering and design. The purpose is to ensure that every activity — from device classification and plan testing through verification, validation and regulatory approvals are accounted for, as well as production directives such as vendor requirements, assembly, packaging and labeling procedures, etc.
The design transfer checklist serves as physical documentation that all transfer-related activities are successfully completed. It’s a valuable internal best practice that can also provide a paper trail for regulatory auditing, which can save time when bringing a new device to market.
Why Partner with Kapstone Medical?
Not surprisingly, medical device manufacturers are called upon to keep and produce precise records of anything related to their product. Design transfer is certainly a leading example of how complex the undertaking can be, and why partnering with a medical device consultant such as Kapstone Medical provides value and peace of mind.
We can come alongside device manufacturers at any point in the process from concept through commercialization and do what’s necessary to ensure quality, accuracy, and consistent success.
Learn more about how Kapstone can help your team navigate other common regulatory complexities in US FDA 510(k) From Concept to Clearance: A Guide for Medical Manufacturers. Click below to download your copy now.
