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DirectoryIT & CommunicationSoftware DevelopmentFeldbrunnenColabON AG
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ColabON AG

Summary

About the company

The core activity of ColabON AG is the development and provision of software solutions for compliance management of medical devices, particularly in the area of quality assurance and management (QMS). The company supports companies in adapting and optimizing their processes and documentation to regulatory requirements, ensuring compliance with standards and regulations such as ISO 13485, CFR Title 21 Part 820 and others.

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Products & services

Industry:Software Development
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5
Medtech Scale Engine
Digital documentation platform for FDA and CE market approval, with standards and regulations identification, licensing of standards, change analysis, gap analysis, and technical documentation.
Digital QMS
Digital, intelligent quality management system with traceability to standards and regulations, digital technical documentation, a global glossary, and global roles.
Traceability and gap analysis
Structured analysis to link standards, guidelines, and specification documents with process or product requirements; including data import, completeness check, and an automated gap report.
Change and impact analysis
Automated assessment of new and old versions of standards or specification documents to determine relevant changes, their influence, and the effects on the compliance system.
Labeling for medical devices
Systematic labeling for medical devices with process description, derivation of labeling requirements from standards and regulations, and support for traceability and specifications.

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Location

Sandmattstrasse 21
4532 Feldbrunnen

At a glance

Legal form
Corporation
UID
CHE-170.956.022
Founded
2020 · 6 years
Last commercial register change
May 22, 2020
Employees
1 to 10

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