ISO 13485 Medical Device Quality Management

⇒ What is ISO 13485 (Medical devices)?

ISO 13485:2016 specifies requirements for quality management systems for medical devices, with a focus on regulatory purposes.

The standard supports organizations involved in medical device activities such as design, manufacture, storage, distribution, installation and servicing. Its requirements help organizations manage processes and demonstrate their ability to meet applicable customer and regulatory requirements.

Certification is not required by the standard itself. Organizations should assess the regulatory requirements that apply to their products and markets.

Read the official ISO 13485 overview or contact IQRA to discuss assessment scope and availability.

Benefits of a Medical Device Quality Management System

  • Improve business performance and enhance business competence.
  • Attract investment and improve brand reputation.
  • Encourage internal communication and raise morale.
  • Increase customer satisfaction.
  • Strengthen effectiveness and efficiency.
  • Enhance internal effectiveness and improve productivity performance through elimination of unnecessary costs.

⇒ ISO 13485 Objectives?

  • Regulatory compliance
  • Consistent product quality
  • Risk management in device development
  • Continuous improvement
  • Customer satisfaction enhancement
  • Effective device supply chain management
  • Thorough documentation and traceability