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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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...

Compliance Lunch Workshop Marion
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Marion Lepmets

CEO
April 20, 2025

Compliance is (finally) on everyone’s radar now that Atlassian is targeting business teams and business users in specific verticals and everyone is talking about solutions rather than apps. This is also why SoftComply hosted the 3rd edition of the Compliance Workshop on April 10, 2025 during Atlassian Team event. The...

Ultimate Guide to ISO 14971 Risk Management
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Marion Lepmets

CEO
April 16, 2025

Who Is This Guide For? At SoftComply, we understand the importance of proper risk management. From costly design changes to product recalls and bad press, not accounting for risks is in fact the single biggest gamble that companies are taking today. If you are a medical device manufacturer, marketer, designer,...