Smart Documentation:
From Regulation to Registrierung
We help medical device companies bring their products to international registration.
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Quicker Sales: Accelerate your medical device time-to-market by up to 12 months.
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Reduce your documentation workload by 50%.
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Maximize your ROI: 90% lower maintenance costs.
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Minimize your compliance risk.
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Choose the right service solution for your needs:
Customized Consulting:
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Tailored guidance from our experts
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Personalized support for your specific challenges
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OR
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Self-Service Data & Software:
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Instant access to the latest standards and regulations
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Powerful tools for efficient compliance management
QMS Data Package
ColabON Intelligent Gap & Traceability Analysis
Your Quality Management System (QMS) is subject to over 10,000 regulatory requirements. ColabON's intelligence has clustered these requirements so you're faster for your Gap Analysis and Traceability.
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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.
