Standard Operation Process Validation

Cogmedix provides contract manufacturing services to a wide range of Class I, Class II, and Class III medical devices. Following a documented and controlled process validation, process plays an important role in our success as your contract manufacturer.

Class I, Class II, and Class III Medical Device Manufacturing and Process Validation

Standard Operating Procedure – Installation Qualification, Operational Qualification and Performance Qualification (IQ OQ PQ)

Following IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification) procedures we ensure that processes and process equipment produce results meeting the pre-determined specifications. Cogmedix also performs documentation validation to remove any residual tribal knowledge and to help you create Standard Operating Procedures that will consistently produce high quality product that meets pre-determined specifications every time.