Velentium Medical designs and manufactures class II and class III medical devices for you.
We are a professional engineering firm that exists to transform your IP into a safe and secure product that will change lives for a better world.
This Quality Manual covers general policies, responsibilities, documentation structure, and process controls to ensure product safety, effectiveness, and regulatory conformity.

ISO 13485 Certified, USA-based FDA registered manufacturer of record, cGMP production. Ready to build for you.

Usability/HFE, electrical, firmware, mechanical, mobile, cloud, and the systems engineering to tie if all together.

Compliant to the FDA premarket and postmarket guidance, we handle device security for you or train you via our virtual course.

Characterization, design verification, high speed manufacturing test, and returned product analysis.