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ISO 13485:2016 Certification | Medical Devices Quality Management System (MDQMS)

ISO 13485:2016 is an internationally accepted standard that defines the requirements for a quality management system (QMS) specific to the medical devices industry. Built upon the framework of ISO 9001:2000, it incorporates additional regulatory and industry-specific requirements to ensure that medical devices meet both customer expectations and legal obligations.

This standard applies to all organizations involved in the design, production, installation, and servicing of medical devices, including manufacturers, distributors, importers, and exporters. ISO 13485 enables these organizations to demonstrate their capability to deliver medical equipment and related services that consistently meet regulatory requirements.

In today’s healthcare landscape, where patient safety and product reliability are critical, ISO 13485 ensures that medical devices are manufactured and delivered under strict quality control, promoting continuous improvement, risk management, and compliance with global legislation.

ISO 13485:2016 Certification – Principles
ISO 13485:2016 Certification – Benefits

Why ISO 13485 Certification?

  • Proves compliance with medical equipment laws and standards

  • Enhances product safety and customer trust

  • Facilitates international trade and market approvals

  • Reduces product risks and operational errors

  • Builds reputation in regulated healthcare industries

Achieving ISO 13485 isn’t just about certification — it’s about proving your organization’s dedication to quality, safety, and legal responsibility in the medical field.

ISO 13485 Certification Process

  • Initial Assessment – Review current QMS against ISO 13485 requirements

  • System Design & Documentation – Develop procedures aligned with legal needs

  • Implementation – Apply system across all medical device processes

  • Internal Audit & Review – Identify gaps and prepare for external audit

  • Certification Audit – Conducted by Gabriel Registrar

  • Certification Award – Provided upon successful compliance

  • Surveillance Audits – Annual monitoring to ensure consistency

This process ensures every step of your operations is compliant, controlled, and documented — crucial for regulated industries

ISO 13485 Certification Cost

Cost depends on:

  • Type and class of medical devices handled

  • Company size and number of sites

  • Complexity of operations and regulatory exposure

  • Existing QMS maturity and documentation

Estimated Cost Range:
✔ Small enterprises: $1,500 – $4,000
✔ Mid to large enterprises: $5,000 – $20,000+

Investment in ISO 13485 brings long-term savings by preventing product failures, delays in approvals, and legal issues.

Reasons to Get ISO 13485

  • Meet EU MDR, FDA, and global device regulations

  • Improve patient and end-user safety

  • Ensure robust documentation and traceability

  • Open doors to international healthcare markets

  • Reduce the risk of compliance violations or recalls

ISO 13485 empowers medical businesses to stand out with a strong, legally compliant, and patient-focused approach.

What is ISO 13485?

ISO 13485 is a QMS standard specifically designed for the medical devices industry, focusing on safety, quality, and regulatory compliance.

Manufacturers, suppliers, service providers, importers, and exporters of medical equipment who want to ensure quality and regulatory alignment.

While not always legally required, it is often a prerequisite for market entry in regulated countries like the U.S., EU, and Canada.

ISO 13485 certification is valid for 3 years, with annual surveillance audits to maintain compliance.

Yes. ISO 13485 is often part of the compliance path for CE marking and is recognized by FDA as a QMS benchmark.

ISO 13485 Certification in Dubai

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