ISO 13485 Medical Devices Management Systems
Applicable to all organizations involved in the design, production, installation and servicing of medical devices and related services.
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Meet Compliance Requirements
Build confidence and trust with stakeholders by implementing a practical framework to meet your regulatory requirements for a medical device quality management system.
Gain Market Access
Whether you are a manufacturer at any stage of the medical device lifecycle, or a supplier, ISO 13485 gives you international recognition for quality management systems. The framework and principles of ISO 13485 sits at the core of additional regulatory requirements like Medical Devices Single Audit Program (MDSAP).
Drive Business Performance
Align your management system with the strategic direction of your organization to improve process efficiency while reducing reputational risks.
Improve Patient Safety and Quality
Protect consumer safety through robust risk management embedded within each processes throughout the medical device lifecycle.
What Is It?
This internationally recognized Standard brings a strengthened process approach to quality management allowing for a framework to comply to regulatory requirements.
- 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
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.
Maximize Your Certification to ISO 13485:2016
Medical Devices Courses & Training
Explore the range of Medical Devices courses we have on offer through SAI Global Assurance Learning.
Medical Devices Training
Take the lead, upskill and advance your medical auditing career. Choose from our courses designed to meet the Medical Devices standard.
Virtual Instructor-Led Training Auditing A Medical Devices Quality Management System ISO 13485:2016
Take an in-depth review of the requirements of the ISO 13485:2016 standard and how they are applied in the context of an audit.
Virtual Instructor-Led Training Auditing ISO 13485:2016 Medical Devices Lead Auditor
Understand the intent and requirements of the ISO 13485:2016 Standard in the context of a quality management system audit.