MediCompli Solution combines your Quality System Documents with FDA 21 CFR 11 Compliant Document Approval Workflows for Medical Device Companies on Atlassian Confluence.
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MediCompli Solution is based on ISO 13485, IEC 62304, ISO 14971 & FDA 21 CFR 820, FDA 21 CFR 11.
Features
FULL QUALITY MANAGEMENT SYSTEM
MediCompli Solution comes with a full Quality Management System that consists of a Quality Manual, a Quality Policy, 20 SOPs and 55 technical document templates pre-filled to fast-track the implementation of your QMS. Just add your company and product development details!
DOCUMENT APPROVAL WORKFLOWS
MediCompli Solution comes with out-of-the-box FDA 21 CFR 11 compliant Document Approval, CAPA, Training and Change Management Workflows for your Quality System documents.
COMPLIANCE ENVIRONMENT
MediCompli Solution includes a Compliance Matrix illustrating how each feature of the solution complies with a 21 CFR 11 requirement and has an IT Policy that describes the compliant configuration of the solution.
CUSTOMIZABLE
MediCompli Solution is fully customizable, both the Quality System documentation as well as the digital document control workflows, to any medical device development project.
INTEGRATION
MediCompli Solution is fully integrated to Atlassian Confluence and thereby to the entire Atlassian Stack.
COMPLIANCE IN ALL PROJECTS
MediCompli Solution supports compliance in all medical device development projects as it provides a home for QMS documentation in Confluence with compliant workflows for each of the documents.
Benefits
SUPPORTS FDA AND CE-MARKING
MediComply Solutions is based on ISO 13485, ISO 14971, IEC 62304, FDA 21 CFR 820 and FDA 21 CFR 11 thus comprehensively focusing on the EU and USA markets.
REDUCES THE COST OF COMPLIANCE
MediCompli Solution provides an affordable compliance solution for medical device companies with a full QMS documentation, compliant digital document control workflows, e-signatures and access management.
MOST COMPETITIVE PRICE
MediCompli Solution is priced annually based on the Confluence user license tier.