MediCompli Solution combines your Quality System Documents with FDA 21 CFR 11 Compliant Document Approval Workflows for Medical Device Companies on Atlassian Confluence.

CHECK OUT THE DEMO VIDEO

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.

PRE-CONFIGURED, MAINTAINED & HOSTED

MediCompli Solution is pre-configured for compliance & hosted on AWS Server – maintained securely for you!

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.