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Stop Document Puzzling.
Build Your TechDoc with Live Regulatory Data.

Traditional eQMS tools sell you isolated templates.But without live standards data, interpreting and building your Technical Documentation takes months.
ColabON delivers a turn-key QMS connected directly to fully licensed regulatory data—saving you 480+ hours of manual linking and interpretation.

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Compliance Challenge
for Startups

​The Two Walls Every MedTech Startup Hits


Most startups think compliance is just about buying QMS templates. The reality is a brutal two-stage administrative overhead that drains your runway:

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  • Wall 1: The QMS Puzzle (480+ Hours): A standard QMS consists of roughly 40 isolated SOPs. Manually cross-referencing and adapting these static text silos takes at least 12 hours per document.

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  • Wall 2: The TechDoc Nightmare (The Blind Spot): Once the QMS is set up, you must build your Technical Documentation. To do this, you have to buy, read, and manually interpret thousands of lines of ISO/IEC standards to derive your product requirements. Without integrated data, you are flying blind.

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This structural flaw of document-based competitors leads to:

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  • 6+ months delay in market access

  • Hidden compliance costs of 60k–300k CHF

  • Avoidable Costly development cycles

  • Unaddressed risks, especially with emerging AI technologies

Verfahren zur Gehirnüberwachung
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Connected Data Over Static Text Silos​​

  • ​Pre-Linked Regulatory Data: Access curated compliance and ISO/IEC standards data directly inside your platform. No more copying and pasting requirements from expensive PDFs.​

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  • Automated Impact Analysis: When a regulation or standard changes, our database maps the impact instantly. The system shows you exactly which product requirements and test cases are affected.

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  • 50% Lower Administration Effort: Because your QMS processes and Technical Documentation live on the same relational database layer, updating one updates the other automatically.

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  • Audit-Ready on Demand: Your Traceability Matrix (RTM) is no longer a fragile, manual Excel export. It is a mathematically precise, live database query.

Document-Based Legacy Tools vs. ColabON’s Regulatory Data Platform

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