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Quality Policy

At TechDevice we strive to consistently provide value to our customers in the areas of quality, delivery, and cost effectivity. Adherence to our Quality Management System, the requirements of our customers, and the regulatory authorities enables us to achieve world class medical device development and manufacturing status. 

Certifications

• ISO 13485:2003 Certification
• ISO 13485:2003 CMDCAS Certification
• MDD Certification
• FMA Certification
• FDA registered - FDA audit 8/04, 12/09
• 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