Before any medical device can be released onto the market, the burden is on device producers to demonstrate that their product does what it’s supposed to. That can be an extremely labor-intensive process, since the FDA demands reams of paperwork documenting everything from the design process to manufacturing specifications.
Most medical device companies have extensive document management systems in place to produce a design history file. But they also need to capture data from the contract manufacturer, including design verification and validation testing, equipment specifications, materials, and technician training. All of this documentation is an integral part of product lifecycle management.
Therefore, it is imperative to understand how the contract manufacturer operates and produces the documentation required by regulators.
Outsourcing medical device production is a big step for many companies. In addition to relying on your contract manufacturer to produce components that are up to design standards, you are also relying on your manufacturer for documentation of their process.
Given the importance of documentation in getting a device to market, it’s essential that the contract manufacturer you rely on can produce documentation that’s up to standard. In your search of a contract manufacturer that you can depend on to deliver high-quality products with consistency you w how to build a medical device from initial design, but how to track the design and production iterations that ultimately lead to the final product.
A traceability matrix is an invaluable tool for following the flow of medical device development from beginning to end. Traceability requires showing the relationships between all of your design controls, including how design inputs relate to design outputs and how design validations relate to end-user needs.
In particular, your contract manufacturer plays a critical role in developing and maintaining the device master record (DMR). The FDA will check the DMR against your design history record (DHR) to ensure consistency before your product goes to market.
The DMR could contain thousands of lines of information for complex products. Your manufacturer should have a computerized system, such as product lifecycle management software, to create and maintain the information needed in the DMR.
It’s important to be aware of the individual responsible for the documentation. Generally, VP of QC, this individual will be highly familiar with all regulatory requirements and it is he or she who reviews and approves the documentation process. This individual should also be responsible for managing any changes to the documentation and building a traceability matrix for regulators.
In addition, your contract manufacturer must take care to document every relevant piece of information around a device’s production process. Too often, small design changes or modifications to equipment are overlooked in document control. A computerized quality management system can help solve this problem.
At Quasar, we believe that our part is beyond simply producing components to spec. We ensure that our medical device partners achieve levels of quality that surpass regulatory compliance. We produce a data master record for clients that fully describes our equipment, any changes to the original device design, and every step of production.
Quasar uses state-of-the-art product lifecycle management and quality systems to better manage medical device document control. Our quality management saves time, eliminates unnecessary costs, and reduces regulatory risks for the device producers we work with. Quasar dedicates significant resources to documentation and quality management. We believe strongly in operational excellence at every level of our organization, and that means that you can rely on Quasar as a partner in meeting all documentation regulations.
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