©2019 BY EVOLVE MANUFACTURING TECHNOLOGIES. WOMAN OWNED BUSINESS.  FDA REGISTERED, ISO 13485:2016, ISO 9001:2015

47300 Bayside Pkwy, Fremont, CA 94538, USA     (510) 690-8959

QUALITY POLICY

Evolve is committed to providing contract manufacturing solutions and services that are on time, reliable, meet performance specifications, and exceed customer expectations.

 

CERTIFICATIONS

Certifications are not only necessary when you select a contract manufacturer, they provide a foundation for the confidence and trust that will grow as you work closely with our team.  Evolve is proud to pass audits with flying colors and maintains its prestigious standing with the British Standard Institute (BSI) certifications process.  Evolve meets all required United States Food and Drug Administration (FDA) Quality System Regulation requirements for medical devices and pharmaceuticals.  With the following certifications to our name, we have built a reputation for providing 100% on-time delivery and 99.7% out-of-box quality

ISO 9001:2015 CERTIFIED

This British Standard Institute (BSI) certification is recognized world-wide as a mark of distinction. ISO 9001:2015 Certification affirms the quality-management system is defined, documented and effectively implemented to meet Customer requirements.  Evolve fully embraces these requirements to improve internal and Customer processes to improve productivity, reliability, and reduce cost

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ISO 13485:2016 CERTIFIED

Without the BSI certification, a company is not entitled to build medical products or equipment.  ISO 13485:2016 certification informs the world that Evolve staff has been through proper training and can provide the thorough documentation in the event of an audit. With Evolve's certification status standing by you, you can be certain that your product is produced in a verifiable way

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FDA REGISTERED

The United States Food & Drug Administration officially authorizes the manufacture of medical devices. Evolve is registered with the United States FDA and California State FDB as a contract manufacturer of medical devices. Evolve has undergone and passed all inspections for the manufacture of medical devices.

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"Excellent Support from Evolve Manufacturing. Assisted us in a critical program transfer in regards to documentation clean up and status updates. Good feedback from our Engineering community and Material teams"

Director of Materials - Biomedical Company