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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
- Customer and Patient Safety Focus
- Compliance with Regulatory Requirements
- Product Traceability and Documentation Control
- Risk-Based Thinking and Management
- Process-Based Approach for Consistency
- Continual Improvement and Monitoring
- Effective Supplier and Outsourced Process Control
ISO 13485:2016 Certification – Benefits
- Ensures Compliance with Medical Regulations Globally
- Improves Quality and Safety of Medical Devices
- Facilitates Market Access in Regulated Countries
- Boosts Customer and Regulatory Confidence
- Reduces Product Recalls and Defects
- Enhances Operational Control and Documentation
- Promotes International Recognition and Trust
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.
Who needs ISO 13485 certification?
Manufacturers, suppliers, service providers, importers, and exporters of medical equipment who want to ensure quality and regulatory alignment.
Is ISO 13485 mandatory?
While not always legally required, it is often a prerequisite for market entry in regulated countries like the U.S., EU, and Canada.
How long is ISO 13485 valid for?
ISO 13485 certification is valid for 3 years, with annual surveillance audits to maintain compliance.
Can ISO 13485 help with CE marking or FDA approval?
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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