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Smart Documentation
from Regulation to Registrierung 

We help medical device companies bring their products to international registration. 

  • Quicker Sales: Accelerate your medical device time-to-market by up to 12 months.

  • Reduce your documentation workload by 50%.

  • Maximize your ROI: 90% lower maintenance costs.

  • Minimize your compliance risk.

Choose the right service solution for your needs: 

Customized Consulting:

  • Tailored guidance from our experts

  • Personalized support for your specific challenges

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OR 

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Self-Service Data & Software:

  • Instant access to the latest standards and regulations

  • Powerful tools for efficient compliance management

Get in touch.  

We're happy to talk to you!

We will send an Newsletter about once a month about a topic we care about. 

We will never spam or sell your info. Ever.

Thank you for your message!

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).

  • MDR or IVDR for medical devices and in vitro diagnostic medical devices in the European Union.

  • SN EN ISO 13485 as a specific European standard.

  • CFRs for the United States.

  • ISO 14971 for risk management, a fundamental aspect of medical device development.

  • ISO/IEC Guide 63 and ISO/TR 24971 to aid in understanding the complexities of the MDR.

  • IEC 62366-1 for usability engineering.

  • IEC 62304 for software-related requirements.

  • ISO 20417 for labeling and information provided with medical devices.

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