ISO 13485 – Medical Devices Quality Management System

ISO 13485 is an internationally recognized standard that outlines the requirements for a quality management system (QMS) specific to the medical devices and pharmaceutical industry. It applies to organizations involved at any stage of the supply chain — from design and development to production, installation, and servicing of medical devices.

The standard supports global harmonization of regulatory requirements, incorporating additional criteria such as risk management, sterile manufacturing processes, and enhanced documentation and record control.

Organizations can pursue ISO 13485 certification independently or in conjunction with ISO 9001. Certification through FS Certifications demonstrates your company’s commitment to consistently delivering safe, effective products and services that meet both customer expectations and regulatory obligations in the medical field.

Key Benefits of ISO 13485 Certification

• Establishes a robust framework for ensuring product quality and consistency

• Enhances competitive advantage in the global medical device market

• Promotes active top management involvement in quality initiatives

• Supports a systematic and effective business approach

• Reduces risks through comprehensive risk management practices

• Helps meet international regulatory requirements for medical device manufacturers

• Aligns with ISO 9001 principles, offering combined benefits of a quality-driven system