MediCompli Solution is based on ISO 13485, IEC 62304, ISO 14971 & FDA 21 CFR 820, FDA 21 CFR 11.
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.
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.
MediCompli Solution is fully customizable, both the Quality System documentation as well as the digital document control workflows, to any medical device development project.
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.
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.