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TechDevice’s quality systems rival even the most respected Fortune 500 medical device firms. And our dedicated staff is committed to delivering the highest level of quality and services in the industry.

Certifications

• ISO 13485:2003 and CMDCAS Certification – June 2005
• FDA registered - FDA audit 8/04
• Design control system compliant with FDA & European regulations
• Experience with the FDA 510(k) clearance process.

Quality Controls

• Incoming/in-process inspection procedures
• Final release procedures
• Operational & manufacturing procedures
• Certificates of Compliance
• Device history records maintained to ensure GMP compliance