“Code Refinery, brings a complete compliance solution prospectively and retrospectively to a client. This includes requirements , specification, verification and validation along with all the prerequisite Design Control documentation and Traceability. Their experience helps to efficiently provide the appropriate level of evidence to document that “we say what we do and do what we say”. Code Refinery has established themselves as a solid development partner.”

Document and perform verification testing of medical device software developed for a diagnostic instrument intended to provide early detection of viral meningitis and aid in clinical diagnosis of a patient. Development must comply with internal quality standards and FDA regulations to allow for an FDA 510(k) device submission.

Code Refinery worked with bioMérieux to quickly assess the current state of development and presented recommendations to meet program goals. We were a to streamline effort by utilizing proven document control procedures, version control and defect management systems. The final project documentation met bioMérieux Corporate Quality Guidelines and standards as well as providing the basis for an eventual FDA 510 (k) device submission and allowed further commercialization efforts to be carried out.