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Comalatech, alongside the great teams at Clearvision and SoftComply, is happy to announce the launch of the MediCompli solution, an end-to-end documentation solution for the Medical Device Software industry. Built specifically for teams looking to build electronic quality management systems in the cloud, you can see the solution for yourself right now at www.medicompli.com

What is MediCompli?

MediCompli was purposely designed to meet the needs of medical device software teams who need a QMS that meets compliance standards like ISO 13485, ISO 14971, IEC 62304, FDA 21 CFR 8203, and FDA 21 CFR 11. It is comprised of four key elements:

  1. A Confluence server instance
  2. The Comala Document Management app
  3. Softcomply’s eQMS app
  4. Altassian Access

Confluence provides the foundation for the QMS, with all of its collaborative power and ability to connect teams to their documentation. eQMS goes a step further by providing pre-loaded document templates that act as a complete road map to ISO and FDA compliance; a team only needs to follow the path laid out by eQMS to have audit-ready content. Meanwhile, Comala Document Management’s approval workflows come pre-configured to meet the above-mentioned standards. Atlassian Access manages user access, completing an important compliance requirement.

All of this lives remotely in the Cloud on an AWS server managed by the experts at Clearvision. Their experience and expertise means that software teams can leave server administration to them and focus on what’s important – developing life-saving medial innovations.

Getting Started with MediCompli

Teams who need a compliant QMS can get started with MediCompli very quickly. A recorded demo of the solution can be found here, and you can learn more about MediCompli at www.medicompli.com.