Certified Quality System

Quality management across all stages of operations

Certified medical device manufacturing environment compliant with EN ISO 13485:2016

At HEPY, quality does not apply solely to the final product. It encompasses all processes carried out within the company — from design and development, through production, to distribution and post-market supervision of medical devices.

Standard for Medical Device Manufacturers

EN ISO 13485:2016 is an international standard specifying requirements for the Quality Management System of medical device manufacturers. Certification does not apply to a single product, but to the entire organizational system, including design and development, production, control and management processes.

The standard focuses on ensuring safety, regulatory compliance and process consistency throughout the entire lifecycle of a medical device.

Scope of the System

Processes Covered by the Quality Management System

Design and Development

Planning and development of medical devices based on documented requirements, risk analysis and controlled design changes.

Production

Execution of manufacturing processes in accordance with approved procedures, parameter control and traceability of materials and components.

Quality Control

Verification of product conformity with technical and regulatory requirements at defined stages of the manufacturing process.

Suppliers

Qualification, evaluation and supervision of suppliers of raw materials, components and services impacting the quality of the medical device.

Documentation

Management of quality documentation, process records and change control in compliance with EN ISO 13485:2016 requirements.

Post-Market Surveillance

Monitoring of medical devices after market placement, analysis of feedback and implementation of corrective and preventive actions.

System Approach

Quality as an Integral Part of Daily Management

The Quality Management System at HEPY constitutes an integral part of daily operational activities. It includes management responsibility, personnel training, risk management, internal audits and continuous process improvement. This structured approach supports consistent medical device quality and sustained compliance with applicable regulatory requirements.

Executive Search
Quality Management System documentation for medical devices

What This Means for Partners

  • Predictability and process consistency
  • Compliance with European Union regulatory requirements
  • Transparency of manufacturing operations
  • Stability of long-term cooperation
Quality Standards

Trust Built on Systems and Processes

A certified Quality Management System compliant with EN ISO 13485:2016 forms the foundation of HEPY’s operations and serves as the basis for cooperation with distribution partners and medical market institutions.