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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SoftComply webinar with BSI and regenold
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Marion Lepmets

CEO
May 27, 2025

If you’re a medical device manufacturer, you already know that compliance isn’t a walk in the park. It’s more like a hike through regulatory terrain with the occasional mountain lion (metaphorically speaking). But don’t panic. We’ve distilled insights from a recent expert-packed webinar to help you navigate the wild world...

medical device risk management guide for FMEA
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Marion Lepmets

CEO
May 15, 2025

In the medical device industry, risk management is not just a regulatory requirement. It is a fundamental practice to ensure the safety, effectiveness and quality of devices that directly impact patient health and wellbeing. If you operate within the medical device industry as a manufacturer, Software as a Medical Device...

Risk Management Software Buyers Guide
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Marion Lepmets

CEO
April 24, 2025

INTRODUCTION If you are a risk management professional or business owner, you understand that organizations today face a complex risk landscape driven by technological advancements, evolving regulatory frameworks, and globalization. Developments in AI, cloud computing, and IoT have introduced significant risks, with cybercriminals using these same tools to launch more...