Certifications

ISO 13485 – Quality Management for Medical Devices

This standard builds upon ISO 9001 quality system requirements, adding specific regulatory requirements for medical device manufacturing to standardize sector regulations.

It applies to manufacturers or suppliers of medical device products or services, such as components, molded plastic parts, subassemblies, packaging, maintenance, installation, or repair of medical devices.

Benefits:

  • Provides a structured framework to demonstrate regulatory compliance.
  • Increases customer trust.
  • Helps organizations showcase their commitment to product and service quality.
  • Enhances recognition and reputation, improving market positioning.
  • Establishes a culture of continuous improvement.