Software Tool Validation in the Medical Device Industry – A White Paper
Marion Lepmets
CEO
March 6, 2023
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Matteo Gubellini
Regulatory Affairs Manager
October 29, 2026
Your procedure is approved. But does it still describe how your team should work? Since its release, you may have changed your development tools, introduced a new supplier or reassigned responsibilities. Findings from a complaint investigation may have highlighted a gap in your processes. Your development team may have outgrown...
Marion Lepmets
CEO
October 24, 2026
SoftComply has been helping companies manage their risks in Jira for over 10 years and we believe that risk management works best when it happens where the work is done. Managing risks inside Jira keeps them connected to the people, deadlines and activities that help reduce and determine whether they...
Marion Lepmets
CEO
October 21, 2026
AI can draft a procedure in seconds. Before anyone follows it however, a person still needs to check that it describes the right process, uses current sources and has been approved for use. In regulated organisations, documents guide work and provide evidence of decisions. Outdated instructions or unsupported claims can...
