At Last, a Compliance Solution for the Medical Devices Industry!

At last, a compliance solution for the Medical Devices industry!

Comalatech

Based on Confluence, MediCompli includes a pre-configured Quality Management System, with out-of-the-box FDA 21 CFR 11 compliant document approval workflows and e-signatures. Fully customizable for additional workflows and compliance requirements ⁠— that’s not even the half of it!

What’s the need?

Experts in the field saw a gap in the medical devices industry, in that no solution existed to help professionals simplify and largely automate compliance management processes based on Confluence.

The goal of MediCompli is to simplify and automate compliance processes so that users can focus on what they do best — improving and saving lives, through medical innovation.

Built by the experts

Three Atlassian partners were involved in the formation of MediCompli:

Comalatech Logo

Comalatech’s approval workflows simplify the process:  Off-the-shelf and easy to navigate workflows, make linking to appropriate spaces possible.

Softcomply

A wealth of regulatory compliance knowledge in the medical devices realm: SoftComply developed a complete Quality Management System, which includes a Quality Manual, Quality Policy, 17 SOPs and 50 document templates pre-filled to fast-track the development and implementation of a QMS.

Clearvision

Let Clearvision do the hosting: Set up, configured, and supported by fully trained, ISO 27001 certified cloud engineers, MediCompli’s dependable and reliable hosting, allows professionals to focus on their job.

Tell me more about the benefits!

MediCompli helps your business through a combination of:

  • Reduced time – It takes time to manage compliant quality management processes, and MediCompli saves this by preconfigured compliant documents and document control.
  • Security and support – Maintained by fully vetted and certified cloud engineers from Atlassian Platinum Solution partner Clearvision.
  • Pay as you grow – Low entry point for start-ups of any size who require compliance from the get-go.
  • Scalability – Add users, products, processes and regulatory requirements as and when needed.

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