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ISO 13485 Certification – Medical Devices Quality Management Systems

Ensure your medical device quality management system (QMS) meets ISO 13485 certification requirements with SGS.

Given the complex nature of the medical device industry, an effective QMS must be more technically driven and requires extensive documentation. ISO 13485 is the QMS standard that provides medical device manufacturers with a framework to demonstrate that they consistently meet customer and regulatory requirements, and are committed to quality and patient safety.

Based on the ISO 9000:2008 series, ISO 13485 uses the process-based approach to ensure the quality of medical device design, manufacturing, installation and service – for all stages of the product life cycle.

ISO 13485 is a minimum requirement for medical device manufacturers and at the core of numerous international market access programs, such as the Medical Device Single Audit Program (MDSAP), CE and UKCA marks.

We independently assess your QMS against ISO 13485 requirements and provide the certification required for market access.

Why choose ISO 13485 certification services from SGS?

We can help you to:

  • Understand the requirements through our internationally recognized ISO 13485 training courses
  • Confirm that your medical device products meet the requirements of the standard
  • Provide proof of compliance with our independent assessment and certification
  • Gain the quality assurance required to meet the demands of stakeholders at every level

We can help you on your journey to ISO 13485 compliance, demonstrating that you meet the regulatory requirements for:

  • Management responsibility
  • Resource management
  • Product realization
  • Measurement, analysis and improvement

Why SGS?

We are the world’s leading provider of testing, inspection and certification services. We are recognized as the global benchmark for quality and integrity. Our 96,000 employees operate a network of 2,700 offices and laboratories, working together to enable a better, safer and more interconnected world.

  • SGS Central América Inc - Guatemala

6a. Calle 14-08 Zona 13,

Ground, 1013,

Guatemala City, Guatemala

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