ISO 13485 Medical Devices Management Systems
Applicable to all organisations involved in the design, production, installation and servicing of medical devices and related services.
Meet Compliance Requirements
Gain Market Access
Drive Business Performance
Improve Patient Safety and Quality
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, organisations 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.