Key Benefits

The Key Changes

How it Works

ISO 13485:2016 medical devices quality management systems specifies the requirements for organizations in any aspect of a medical device lifecycle, including both product and related services.

This internationally recognized Standard brings a strengthened process approach to quality management allowing for a framework to comply to regulatory requirements.

Implement a structured framework that aligns processes with the strategic direction of the business.

  • Increase patient safety and quality, protecting your brand
  • Achieve regulatory compliance requirements
  • Achieve organizational strategic objectives
  • Improve process efficiency and lower costs
  • Gain market access

ISO 13485 applies a risk-based approach to the quality management of medical devices.
The framework includes:

Quality Management System

Following the requirements of ISO 9001, ISO 13485 follows the structure to implement a quality management system including the requirements to document processes for the highly regulated medical device industry. Expands the terms of the Standard to include areas such as clinical evaluation, software, medical device families, post-market surveillance, Distributors and Importers.

Management Responsibility

Top management sit at the center of the organization's success, and are therefore required to establish the quality processes and objectives, as well as conduct reviews to ensure the business is meeting customer expectations.

Resource Management

Only applicable if relevant, implement the right people and infrastructure to foster a positive work environment that sets the organization up to succeed.

Product Realization

Only applicable if relevant, the Standard references the requirements the organization needs to comply with in planning, designing and developing, purchasing and monitoring of the medical device.

Measurement, Analysis, and Improvement

Only applicable if relevant, organizations will need to monitor and measure the performance of the business processes, including meeting customer expectations. Internal audits enable opportunities for continuous improvement and corrective action.

Whether you're new to ISO 13485 or are looking to transfer your certification, we can assist you.

1. Getting Started


2. Implement the Standard

  • Contact SAI Global's dedicated team to discuss your requirements, timeframes and costs.
  • Review and accept proposal to book audit dates
  • Take an optional pre-assessment
  • Perform a Gap Analysis


3. Certification

  • Undertake Stage 1 audit
  • Complete a detailed Stage 2 certification audit
  • Upon successful certification, display the 'Five Ticks' Standards Mark


4. Maintenance

  • Conduct Surveillance Audits annually
  • Recertify to ISO 13485 every 3 years
  • Establish a continuous improvement culture


5. Maximizing your Certification

  • Market for brand and promotional benefits
  • Optimize commercial teams
  • Ensure shareholder and stakeholder awareness


Contact us about your certification journey

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