Medical Device Validation
Industry: Medical Devices
INTRODUCTIONA Fortune 500 medical device company required assistance with validating test systems and characterizing test processes for a device assembly line. Validations were to occur in parallel for various test systems and multiple times as numerous validated devices were required for staggered clinical trials.
SOLUTIONOptimation was able to quickly become integrated as badged contractors within the medical company's internal system and has undergone document submission, quality and ethics training under medical company's Quality Management System. This allowed Optimation to become an extension of the company's team by authorizing Optimation to create, execute and submit test plans, documents, and reports through the company's internal document control system.
Optimation has been able to validate various test systems multiple times through the life of upgrades and testing. Optimation's familiarity with Part 820 and ISO-13485 standards in addition to being certified in LabVIEW has allowed the team to be highly effective and efficient at providing test system validation services. During validation, Optimation has helped to create and execute: System Requirement Specifications, Software Validation Plans, Installation Qualification Plans, Operation Qualification Plans, Performance Qualification Plans, Unit Test Plans, Preventative Maintenance Schedules and Software Packages.
RESULTSDue to Optimation's effectiveness in validation, debugging and support of the existing systems, the customer has chosen Optimation to design, fabricate, program and validate new test systems for the existing and future manufacturing lines. Optimation will be designing, programming, fabricating, wiring and validating the new stations.
By contracting Optimation, the customer was able to save money by utilizing internal resources on other company projects. Now that Optimation is integrated into the customer's systems and familiar with the company processes, Optimation's full service capabilities can be rapidly deployed to drastically reduce the time from project conception to completion.
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