As an OEM producing a new product or continuing to market an existing product, working with an experienced contract manufacturing service is a critical part of your ability to compete in the market.
This is true in any industry, but it becomes a crucial factor in the medical device industry. Here, not only does the ability to meet production requirements play a part in the selection of contract manufacturing services but so does the ability to maintain strict quality control and production standards.
Understanding of Verification and Materials Sourcing
Trusting the production of parts and components or the full medical device to contract manufacturing services requires that the contract manufacturer (CM) understands the importance of documentation on all types of materials used in the product.
An experienced CM knows the process and the procedures for maintaining the correct documentation and sourcing materials from reliable, quality suppliers that are also experienced in producing materials used in medical device manufacturing.
Quality Control and Standards
In addition to maintaining the required documentation and selection process for materials, the experienced contract manufacturing services have well-established quality control measures in place throughout the production. Look specifically for ISO 9001 for general process quality control, as well as for ISO 13485 certification, which is specifically for the production of medical devices.
The contract manufacturer should also be FDA registered, and the quality systems they have in place should be Quality System Regulation 21 CFR Part 820 compliant. This is a standard that focuses on current good manufacturing processes (cGMP) that are both mandated by the FDA for all devices designed for human use as well as creates standards for product design for increased safety and improvement.
The ability to produce medical devices to a specific schedule as well as the cost for the contract are also factors to consider with any experienced CM.