ISO 13485:2016 - Medical Devices

ISO 13485 demonstrates your dedication to quality management for medical devices and associated services within the medical sector.

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What is ISO 13485:2016?

ISO 13485 set by the International Organization for Standardization (ISO), establishes a Quality Management System (QMS) tailored for the medical industry, encompassing medical devices and associated services.

The standard ensures organizations consistently fulfill client needs and comply with relevant regulations, providing a framework for quality design, manufacturing, and installation of medical devices globally.

ISO 13485 aids organizations in complying with medical regulations, showcasing their dedication to delivering high-quality products and effective services.

  • Demonstrate compliance.
  • Build client confidence.
  • Access markets and tenders.
  • Realize cost savings.
  • Reduce waste & save costs.

Benefits of ISO 13485:2016

Establishing a QMS for medical devices offers advantages to organizations, regardless of size, operating within the medical device industry.

ISO 13485 certification empowers medical device businesses to demonstrate their dedication to excellence across development, production, and installation of medical devices.

Given the complex regulatory landscape and international standards within the medical appliance industry, it's imperative for your organization to consistently deliver safe and effective devices.

  • Improve detection of manufacture faults.
  • Build client trust and satisfaction.
  • Enhance supply chain quality and reliability.
  • Boost production quality and reduce waste.
  • Meet medical safety standards.
  • Gain competitive advantage.

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