Quality & Regulatory Compliance

Hainwise manufactures medical guidewires and catheters under a structured quality management system aligned with international regulatory requirements.

All projects are planned, implemented, and controlled in accordance with applicable standards, ensuring product safety, traceability, and consistent performance.

Quality Policy

• Technical rigor in design and manufacturing

• Strict adherence to quality standards

• Compliance-driven operational management

Quality Management System

• EN ISO 13485:2016 certified

• Subject to regular internal and external audits

• Documented design control and risk management processes

• Full batch traceability and controlled production procedures

Regulatory Status

Hainwise maintains regulatory systems aligned with major international markets.

• Regulation (EU) 2017/745 (MDR) – documentation in preparation

• FDA Establishment Registration

• Certificate to Foreign Government (CFG)

• Compliance with 21 CFR requirements

Certification status may vary by product model and intended market.

Regulatory & Post-Market Activities

• Complaint handling and reporting procedures

• Adverse event investigation and documentation

• Post-market surveillance and trend analysis

• Periodic Safety Update Reports (PSURs)

• Vigilance systems to support timely corrective and preventive actions (CAPA)

Hainwise operates in accordance with applicable laws, regulatory requirements, and established corporate compliance standards to ensure ethical and responsible business conduct.