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Beyond Configuration: How Consultants Empower Regulated Industries

Picture of Monika Isak

Monika Isak

Head of Growth
June 2, 2025

For regulated industries – such as Pharma, MedTech, FinTech and Aviation – compliance isn’t optional, it’s mandatory. Tools like Jira and Confluence are powerful, but their true potential is only unlocked when they are configured to meet these specific requirements. This is where specialized consultants come into play, offering expertise…

Agile

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Agile
Picture of Monika Isak

Monika Isak

Head of Growth
June 2, 2025

For regulated industries – such as Pharma, MedTech, FinTech and Aviation – compliance isn’t optional, it’s mandatory. Tools like Jira and Confluence are powerful, but their true potential is only unlocked when they are configured to meet these specific requirements. This is where specialized consultants come into play, offering expertise...

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...

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,...