ISO 13485 Certification

Medical Device Quality Management System

ISO 13485 Certification

Enhance Your Medical Device Quality with 13485:2016 Certification. In the highly regulated medical device industry, ensuring quality and compliance with international standards is crucial. Our comprehensive certification services cover all aspects of implementing and maintaining a Medical Device Quality Management System (QMS).


ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support). It can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations.

Requirements are applicable to organizations regardless of their size and regardless of their type except where explicitly stated. Wherever requirements are specified as applying to medical devices, the requirements apply equally to associated services as supplied by the organization.


Our expert consultants will guide you through the entire  process, including:

  • Gap analysis and readiness assessment
  • Documentation review and development
  • Implementation support and training
  • Internal audit preparation
  • Certification audit assistance

By achieving ISO 13485, you will:

  • Enhance product quality and safety
  • Improve regulatory compliance
  • Increase market access and credibility
  • Streamline processes and drive efficiency
  • Mitigate risks and errors
Cost Considerations

The ISO 13485 cost of obtaining certification can vary based on factors such as company size, scope of operations, and assistance required. Contact us for a customized quote tailored to your specific needs and budget.

ISO 13485 Certification
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