Shanghai Huazhou (HZ PSA) is a medical device manufacturer with globally recognized quality and regulatory compliance, ensuring patient safety through certified excellence.
These certifications cover the full lifecycle of our medical device manufacturing, from initial design concepts to high-precision sterile production in controlled environments.
Our facilities operate under a certified ISO 13485:2016 quality management system, covering design, production and final inspection of medical devices.
Products are manufactured in accordance with EU Medical Device Regulation (MDR 2017/745) requirements for safety, performance and clinical evaluation.
Shanghai Huazhou (HZ PSA) maintains FDA facility registration and follows applicable Quality System Regulation (21 CFR Part 820) requirements.
Selected wound dressing products are tested according to EN 13726 to verify absorption, moisture vapor transmission and other key performance parameters.
Each production batch is traceable from raw material to finished goods, with full documentation of in-process controls and final release testing.
We undergo scheduled internal audits and external audits by notified bodies and regulatory authorities to maintain continuous compliance.
Documentation and technical files are prepared to support registrations and tenders in key global markets across Asia, Europe and the Americas.
HZ PSA integrates environmental and social responsibility into its quality system, ensuring sustainable production and a safe environment for our global community.
We work with suppliers to reduce waste, optimize packaging and support responsible sourcing of raw materials.
Production areas follow strict hygiene, safety and training standards to protect employees and ensure consistent product quality.
We collaborate with healthcare brands and distributors who share our commitment to patient safety and regulatory compliance.