Price Plans
Transparente Preisgestaltung:
Unser Preismodell basiert auf einem monatlichen Preis pro Prozessbeschreibung. Dabei gilt ein Minimum von 12 zu erfassenden Prozessen.
Sicherung Ihres Prozesswissens:
Durch die initiale Erfassung Ihrer Prozesse bewahren wir Ihr wertvolles Prozesswissen und stellen sicher, dass es im Zuge der digitalen Transformation nicht verloren geht.
Umfassende regulatorische Abdeckung:
Jedes unserer Pakete beinhaltet ein umfassendes regulatorisches Datenpaket, das alle Anforderungen eines QMS für Medizinprodukte oder IVDs erfüllt. Dies ermöglicht eine detaillierte Rückverfolgbarkeit zwischen einzelnen Anforderungen Klauseln und den entsprechenden Prozess Bausteinen.
Planbare Prozessgrößen:
Basierend auf unserer Erfahrung gehen wir davon aus, dass eine Prozessbeschreibung im Durchschnitt nicht mehr als 20 Prozessbausteine umfasst.
Self-managed-QMS
CHF 3'200
per Month & SOP, billed annually
min. 12 SOPs
+CHF 3'200 initial
digitale Transformation pro SOP
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Comprehensive Regulatory Data Package for Medical Devices*
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Live-versioned process descriptions with modular process blocks
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Atomic traceability between sections and process blocks
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Redundancy-free digital template content
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10 standard user licenses (ISO & IEC) for one site (costs included)
Serviced-QMS & Impact Analyse
CHF 4'800
per Month & SOP, billed anualy
min. 12 SOPs
+CHF 3'200 initial
digitale Transformation per SOP
All Prior Features Plus These Exclusive Benefits:
-
Stay Compliant: Regulatory Change Impact Assessment Incl.
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Unlimited Standard User Licences for 5 Sites (Cost included)
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Expandable Medical Device Regulatory Database
Corporate-Certified
Price Upon Request
per Monat & SOP, billed annually
min. 12 SOPs
+CHF 3'200 initial
digitale Transformation per SOP
All Prior Features Plus These Exclusive Benefits:
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24h Premium-Support
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Multi-Language Processes with AI Translation Capability
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API to Document Management System
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API to Requirement Engineering Tool
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Certification Package for ISO 13485
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Certification Package Cyber Security for ISO 27000
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Digital Signature and Computer System Validation Package
Product Compliance
CHF 1'800
per Monat & Product, billed annually
e.g. IEC 60601-1 SER
ca. 11 standards
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Online Product Requirement Interpretation Functionality
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Ready for Interpretation: IEC / ISO in Clause Resolution
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Systematic & Atomic Traceability to Product Requirement
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10 IEC Standard Users Licences for 1 Site (Cost incl.)
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Expandable with any ISO, IEC or other Regulatory Data
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Compliance Reporting per Standard or Regulation
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10standard user licenses (ISO & IEC) for one site (costs included)
QMS Datenpaket
Integrate ColabON into Your Compliance Infrastructure
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Any additional data package (e.g. regulation, standard, guideline)
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Interface to Document Management System
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Interface to Requirement Engineering Tool
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Certification Package for ISO 13485
-
Certification Package Cyber Security for ISO 27000
-
Digital Signature and Computer System Validation Package for ISO 13485
-
Multi-Language Processes with AI Translation Capability
Features
01.
Access the latest regulatory information, officially licensed and promptly accessible online.
02.
Live QMS with Version-controlled Process Elements
03.
Atomic Traceability: the ability to trace every element of a process or product back to its original regulatory requirement.
04.
Impact Analysis: Identify regulatory changes early and assess their impact quickly.
05.
REAL-TIME QMS Reporting and Dashboard
