Quality & Regulatory Compliance

XINZIFER automatic mask machine factory,founded in 1999,is a professional equipment manufacturer integrating scientific research, manufacturing, sales and service, and a high-end manufacturing enterprise of non-woven deep processing equipment.Every product is manufactured to exact specification, in full compliance with FDA guidelines, at one of our ISO-certified facilities. We host 100+ audits per year from customers and regulatory bodies.

Our certifications and registrations:

ISO 13485 and 14971 Risk Management Certified
FDA Registered and compliant with the Quality System Regulation
Class I, II, and III medical devices, including Premarket Approval (PMA) products
Class 7 and Class 8 Cleanroom Controlled Environments
US FDA 21 CFR Part 820 compliance
Canadian Medical Device Conformity Assessment System compliance
Medical Device Single Audit Program (MDSAP)