Domico Med-Device is FDA registered as a Manufacturer, Contract
Manufacturer and Specification Developer. We seek Quality System
Regulation (QSR) compliance through our quality management system
and product registrations.
To promote broad market access, Domico Med-Device’s quality
management system is certified to ISO13485:2016 --- Medical Devices -
Quality Management Systems- Requirements for regulatory purposes
including design controls.
We work to promote a culture of quality and seek compliance with all
relevant regulatory requirements and international medical device
equipment safety standards, including: IEC 60601, IEC 62366-1, IEC 14971
and ISO 10993.