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ColabON's Digital QMS
Embedded in ColabON's Intelligent Data Platform
Always Audit Ready
Limitations of Legacy eQMS Solutions:
• Document isolation within departmental data silos
• Duplication of process descriptions and template management
• Lack of data connectivity across systems
• Significant manual administration due to absent automation
• High volatility: Process and requirement modifications rapidly outdate documentation
ColabON's Digital QMS
Connects to Your Data
Smart Gap Analysis Proposes Automatic Links
10,000+ Regulatory Requirements Ready for Process Integration
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MDSAP for a harmonized approach to regulatory requirements in Australia, Brazil, Canada, Japan, and the US (with potential future inclusion of Switzerland).
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MDR or IVDR for medical devices and in vitro diagnostic medical devices in the European Union.
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SN EN ISO 13485 as a specific European standard.
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CFRs for the United States.
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ISO 14971 for risk management, a fundamental aspect of medical device development.
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ISO/IEC Guide 63 and ISO/TR 24971 to aid in understanding the complexities of the MDR.
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IEC 62366-1 for usability engineering.
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IEC 62304 for software-related requirements.
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ISO 20417 for labeling and information provided with medical devices.
Customizable to your needs
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