Concordia Medical has established a disciplined program management system within its ISO certified and QSR compliant quality systems for design control. Our engineering, development, manufacturing, and quality teams work in close cooperation with our customer’s counterparts to define key design inputs and performance specifications while taking a project through a multi phase design process that typically includes the following:

• Feasibility Samples/Prototyping
• Risk Management
• Process Development
• Installation Qualifications (IQ)
• Operational Qualifications (OQ)
• Process Qualifications (PQ)
• Transfer to Manufacturing

Concordia’s Team has the expertise to help our partners commercialize their medical devices. Concordia is able to provide design control support, validation protocols and reports, test method validation, statistical analysis, and controlled manufacturing processes to our customers. Concordia is committed to ensuring all aspects of medical device design, development, and manufacturing fulfill our customer’s needs and comply with regulatory requirements.