Quality Assurance and Regulatory Affairs Consulting and Compliance

Our dedicated quality assurance team is experienced in medical device design and manufacturing, and sterilization, providing client assistance in the many areas of Quality Assurance and Regulatory Affairs. Enova’s familiarity with the design control process enables us to set up systems to account for the following vital components of your design control process:

Maintain device master records in accordance with GMP guidelines

Record Device History Files

Certify and trace lots

Consult on 510(k), IDE, PMA requirements

Validate processes

Act as a regulatory liaison with government agencies

Review and train for all assembly processes

Testimonial

Enova gets it! Enova does it! Enova is a tremendous resource to us and our broader medical device community – offering full service “Concept-to-Commercialization” capabilities at a single site.

We’ve collaborated with Enova for over two years for our OEM/Contract Manufacturing services. Enova’s commitment to providing a full service/turnkey operation including front-end product development, material procurement, inventory control, and sterilization makes for a great and successful partnership that we enjoy, and we look forward to growing together.

Gene Berghoff
Stereotaxis