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.