For Medical Devices
Reducing the Documentation Burden in Design Control
By Matthew M. Lowe
Advantages of a Web-based Design Control System
The design and development of medical devices is a challenging endeavor in and of itself. Add to that the FDA requirements for medical device developers, and the task can seem insurmountable. Aside from the design and testing of devices, development engineers must ensure that all of the necessary documentation is in place to demonstrate compliance with design controls. It is not uncommon for a product to generate several hundred pages or more of documentation.
Let’s discuss the different elements of design control, and how to reduce the overall documentation burden.
Elements of Design Control
What is design control? It refers to procedures followed to ensure that the design of a device has been adequately tested and correctly transferred into commercial production.
Design and Development Planning: Under the Quality System Regulation (QSR), a manufacturer must establish and maintain plans that describe the design and development activities and define responsibility for implementation.
Design Input: It’s defined as the “physical and performance requirements of a device that are used as a basis for device.” Under the QSR, design input requirements must be documented, reviewed, and approved by a designated individual(s). Common sources of design input include: customer complaints, MDRs (medical device reporting), service reports, corrective action/preventive action, and marketing surveys. Design input requirements must be easily measured and have quantitative limits.
Design Output: This refers to the finished device, but it also includes all documentation of the activities performed during the development process that verify that the design input requirements were met. Further, any item that serves as a basis for the finished device specifications are considered design output.
Design Review: The QSR requires formal documented reviews of the design results at appropriate stages of the design development. This is critical to the efficacy of design control, and ultimately, the market success of the device.
Design Verification: This is the process by which design outputs are compared to design input requirements to determine whether they have been met. Design verification may take a number of different forms, including Failure Modes and Effects Analysis (Design FMEA), bench-top tests and quality inspections, and design trace matrix.
Design Validation: According to the QSR, validation testing must be performed on actual production units or their equivalents. When equivalents are used, the manufacturer must provide documentation that clearly demonstrates the equality. Companies should strive to produce their test units in an environment as close to the final production environment as possible.
Design Transfer: At minimum, the design transfer procedures must in some way assess the completeness and correctness of the production specifications. The specification must be reviewed and approved and placed under the formal change control process. Most importantly, the procedures must ensure that product is manufactured only to the latest, approved revision of the Device Master Record.
Design Changes: Once the design input requirements have been approved, any changes to the input requirements are subject to formal change control. Furthermore, once the design output specifications have been verified and validated, any changes also require formal change control.
Design History File: This serves as a repository for all of the documentation from the design control process. Each of the above elements produces one or more documents that should reside in the DHF. When assembled properly, the DHF serves as a complete record of the design and will likely be referenced throughout the life of a product.
Advantages of a Web-based Design Control System
The design control process can generate a large amount of documentation during the development of a single product. Furthermore, each element requires a review and approval process, and in some cases, formal change control. All of this represents a great deal of time and resources.
A Web-based software solution can help reduce this burden, while at the same time improving the quality and accessibility of the end result, the DHF. An integrated system would yield the greatest benefits in terms of efficiency and efficacy. Consider the integration of the following:
Integrate Design Control Process with ERP System: Such an integration promises a smooth transfer of the design to manufacturing and eliminates the need for duplication of work entering data into two separate software solutions.
Integrate Design Control Process with Quality System: By integrating these two, design teams will have ready access to customer complaint data and product failures for implementation into design input requirements. Likewise, quality personnel will have ready access to design documents for use in the CAPA process and risk analysis through the use of FMEAs.
A Web-based system offers many benefits in managing the design control process. Time spent documenting is greatly reduced, especially in the review and approval process. Most of all, manufacturers can be confident that the time spent in documenting the design will not be wasted later because of inability to locate and leverage the documentation.
About the Author
Matthew M. Lowe, a product manager at MasterControl Inc., is a mechanical engineer with almost a decade of experience as a product development engineer and a product manager in the medical device industry.
Learn more about reducing the documentation burden in design control: