This is an exciting time. Everything is in place. Yet there is no room for error. When it's time to fabricate the device, your manufacturing engineering team comes front and center. Design approval is where the manufacturing process is planned, tested, validated, and confirmed! Do you have a dedicated manufacturing engineering team in place to ensure consistent quality?
Build in quality and safety
The manufacturing of your medical device is one of the critical last-steps before going to market. Do you have dedicated resources to direct and check all the details? Machine settings, temperatures, calibrations and duration are just some of the manufacturing tasks that require validation and documentation.
Anticipate, test and validate
The ideal packaging for the size, weight, assembly and components of every medical device makes each system one-of-a-kind. Sterile barriers must be strong enough to withstand transit conditions and handling until use. Your manufacturing engineers ensure that everything is produced to design specs and safety requirements.