MEDICAL DEVICE QUALITY MANAGEMENT SYSTEM FOR FDA APPROVAL AND CE-MARKING.

STAY
COMPLIANT

MediCompli is a turnkey 21 CFR 11 compliant document management system, with pre-configured QMS content and formal approval workflows. It is based on Confluence with integrated software modules configured specifically for the medical devices industry.

MediCompli simplifies building documentation so you can focus on what really matters — improving and saving lives through medical innovation.

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DEMO

MEDICOMPLI
OFF THE SHELF

An electronic records management system based on Atlassian Confluence and a user & access management dashboard based on Atlassian Crowd. A complete Quality Management System including a Quality Manual, a Quality Policy, 17 SOPs and 50 document templates pre-filled to fast-track the development and implementation of your QMS.

Just add your company and product development details to become compliant with ISO 13485, IEC 62304, ISO 14971 and 21 CFR 820. There’s Customized workflows, already linked to the appropriate spaces, with electronic signatures, for a range of applications.

Medical Device Regulatory Compliance Solution based on: 21 CFR 11, 21 CFR 820, IEC 62304, ISO13485, ISO14971.

Quality Manual & Quality policy, 17 SOPs, 50 Technical Document Templates and an example QMS structure you can easily follow.

Customized workflows for QMS documentation review, approval and obsoletion, product and design documentation review and approval, training record processing and CAPA management.

Designed for teams striving to comply with MDR.

Technology to Create and Collaborate. Comalatech are creators of innovative and powerful collaboration tools for the Atlassian Confluence ecosystem.

SoftComply provides integrated, fully customisable, low cost tools on Atlassian platform for electronic quality management system and risk management.

Clearvision provide Consultancy, technical implementation, hosting, training, and support packages for Jira, Confluence, and the Atlassian stack.

BENEFITS

MediCompli simplifies your quality and compliance related processes so you can focus on innovation.

Reduces compliance costs

MediCompli automates regulatory compliance with pre-configured compliant workflows and full QMS documentation.

Support FDA & CE-marking

MediCompli is comprehensively focused on the EU and US markets helping users fulfill their requirements for ISO 13485, IEC 62304, ISO 14971, 21 CFR 820 and 21 CFR 11.

Cloud based

Hosted via Amazon Web Services (AWS) — the world’s most trusted cloud infrastructure.

Start-up friendly

Low entry point for start-ups of any size that want compliance from the start.

Secure and supported

Set up, configured and supported by Clearvision’s fully trained and certified cloud engineers. Clearvision is an ISO 27001 certified partner.

Customizable

Fully customizable to fit any medical device development project!

Scalable

Add more users, products, processes and regulatory requirements. Just grow.

Enterprise class

MediCompli is based on Atlassian Confluence, a top enterprise software product with 1M + users worldwide.

Expertise

Combining Softcomply’s medical compliance expertise with Comalatech’s approval workflows and Clearvision’s Cloud & Atlassian experience.