Quality

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We proudly hold an ISO 13485 certificate, underscoring our commitment to the highest standards in medical device manufacturing. This certification is pivotal for our customers, providing assurance that our products are developed under stringent quality management systems. The ISO 13485 certificate is an internationally recognized standard that specifies requirements for a comprehensive quality management system in the design and manufacture of medical devices. ISO13485 focuses on critical aspects such as product traceability, cleanliness in product assembly, and rigorous processes for risk identification and management, ensuring a systematic approach to quality assurance and continuous improvement in the medical device industry.

Experience reliable and consistent manufacturing with a variety of controlled environments including Class 7 and Class 8 cleanrooms.

Innovize and CMMI Partnership with the FDA

The Medical Device Discovery Appraisal Program (MDDAP) provides the model and method for the Case for Quality Voluntary Improvement Program (VIP)—a collaborative initiative between FDA CDRH, MDIC, ISACA, and the medical device industry.

The MDDAP framework is a tailored version of the CMMI model created specifically for the medical device industry which enables device makers to measure their capability to produce high-quality devices. It’s the first Case for Quality program that’s recognized by the FDA to offer participants regulatory opportunities that help accelerate improvements to device quality and manufacturing.

Innovize has been a participant in the CMMI program since its inception in 2016.

Benefits for our customers who also participate in the MDDAP/CMMI program

Expedited approval pathway for manufacturing module submissions to FDA
Expedited approval pathway for manufacturing process changes to FDA