Quality Engineered into Every Stage #
Hsiner describes quality not as a final checkpoint but as a standard built in from the first step. The quality management system is built around ISO 13485, with standard operating procedures and traceable records at every stage — from supplier management and incoming inspection to in-process control and final release.
Organization #
- QA (Quality Assurance) — manages system maintenance, internal audits and complaint handling.
- QC (Quality Control) — performs physical inspections.
- Regulatory Affairs — operates independently, managing product registrations and technical documentation for market access across countries.
Clear accountability and mutual checks are intended to ensure the system is practiced daily, not only documented. The separation of regulatory affairs allows Hsiner to meet multi-market compliance requirements without compromising the independence of quality decisions.
Quality System Certifications #
- ISO 13485 Certified
- MDSAP (Medical Device Single Audit Program) Certified
- Japanese Overseas Manufacturer Accreditation (QMS)
Product Market Approvals #
- U.S. FDA 510(k) Clearance
- EU CE Mark (MDD obtained; MDR transition in progress)
- China CFDA Approval
- South Korea KFDA Approval
- Taiwan GMP Certification
Quality Commitment #
Hsiner states that every inspection report, traceability record and internal audit serves one purpose: ensuring that every product delivered can be safely used on patients. This standard has not changed in over thirty years.
Verify the Certificates #
Certificate documents are available from the official download page, including CFDA, FDA, BSI and DNV confirmation letters, CE certificate, ISO 13485 certificates from DNV and BSI, Japanese overseas manufacturing accreditation and MDSAP.
Download certificates · International certifications summary · Official quality page