Quality ISO Certified Medical Device Manufacturing

Quality Assurance

We understand the importance of manufacturing quality devices to your specification every time. Our Quality Management averages 15 years of experience in quality systems and reliability. We use the APQP process to ensure quality is built in. We track 13 key metrics within our Quality System to help ensure continuous improvement.

Registrations and Certifications

• ISO 13485:2003
• ISO 9001:2008
• FDA Registered
• Licensed in Canada

Supplier Quality

Our incoming component inspection process is designed to minimize risk and waste while maximizing quality and throughput. We establish win-win partnerships with our suppliers as they are critical to our success and yours. We evaluate and monitor our suppliers through a scoring process that helps ensure all expectations are being met.