HomeservicesISO 13485 Quality Management System for Medical Device Manufacturers

ISO 13485 Quality Management System for Medical Device Manufacturers

ISO 13485 QUALITY MANAGEMENT SYSTEM FOR MEDICAL DEVICE MANUFACTURERS

ISO 13485 is a critical guideline that ensures products meet minimum health, safety, and security requirements, with particular importance placed on sterilization and hygiene. It includes specific requirements for sterile medical devices and serves as a guide for determining the risk classifications of medical devices.

This standard specifies the requirements for a quality management system that can be used by an organization involved in the design and development, production, installation, and servicing of medical devices, as well as the design, development, and provision of related services. It includes more comprehensive and specialized quality system requirements than ISO 9001 for organizations seeking to demonstrate their ability to consistently meet customer and regulatory requirements applicable to medical devices and related services.
ISO 13485 is based on the ISO 9001 standard. Its primary objective is to define the specific requirements that quality systems must meet for manufacturers operating in the medical device trade and manufacturing sectors.

Benefits of the ISO 13485 Standard

  • Enables medical devices to achieve CE marking,

  • Ensures compliance with regulations of the Ministry of Health,

  • Ensures compliance with European Union legislation,

  • Increases customer confidence,

  • Provides acceptance at national and international levels.