Succeed.
Quality Management System
The eQMS is a general cross-industry electronic ISO 9001 quality management system - ready to use for you.
For medical device companies a specialized version - audited and compliant to ISO 13485, MDR and MDSAP is available. All versions are fully customizable and can scale with your business.
General eQMS - ISO 9001
​Included
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Setup and initial validation of a Confluence Cloud - Instance owned by you
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Implementation of eQMS with quality-manual, quality- and risk-policy, QMS-procedures all required templates - ready to use
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Implementation and training of users
eQMS for Medical Device and IVD Manufacturers
Compliance
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Regulation 2017/745 (MDR)
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EN ISO 13485:2016
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21 CFR Part 820, Part 11, ...
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MDSAP, ...
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​Included
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Setup and initial validation of a Confluence Cloud - Instance owned by you
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Implementation of eQMS with quality-manual, quality- and risk-policy, 26 QMS-procedures with 78 templates - ready to use
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Implementation and training of users