Software Tool Validation in the Medical Device Industry – A White Paper

March 6, 2023

WHITE PAPER ON REGULATORY REQUIREMENTS AND BEST PRACTICES FOR VALIDATION



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Xray SoftComply Risk Based Testing Solution
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Marion Lepmets

CEO
July 7, 2026

Risk management is a critical part of product development and QA, especially in regulated industries where every feature must meet strict safety and compliance standards. Yet, as teams move faster in agile environments, managing the connection between risk and testing often becomes messy or manual. What if your risk management...

Frictionless CISO in Jira
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Marion Lepmets

CEO
July 2, 2026

What if your next ISO 27001 audit required almost no preparation? That’s exactly how Lemuel Valdez, CISO at Cobham Satcom, approaches security. Instead of scrambling to collect evidence before an audit, he builds systems where audit readiness is simply a byproduct of everyday work. “Controls, risk approvals, documents and evidence...

e-signature
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Matteo Gubellini

Regulatory Affairs Manager
June 30, 2026

Not every Confluence e-signature app is designed for regulated industries. This guide explains how to evaluate Atlassian Marketplace apps against 21 CFR Part 11 and choose the right solution for MedTech, pharma, and biotech teams. Looking for an E-Signature App for Confluence? Open the Atlassian Marketplace and search for electronic...