Meet Our Guest: Marion from SoftComply

Marion has an impressive background that bridges software engineering and regulatory compliance, with a particular focus on medical device regulations. After working in academia, she founded SoftComply to help MedTech startups navigate the complex world of compliance with practical, affordable solutions.

SoftComply’s mission? To make compliance faster, automated, and seamlessly integrated into the tools companies already use, like Jira.

Key Topics from the Episode

1. The Role of Compliance in Innovation

While many see compliance as an obstacle, Marion explains how it’s actually a foundation for safer, more reliable innovation—especially in industries like healthcare and software development. She discusses:

• Why compliance doesn’t have to be slow and painful.

• How automation can speed up regulatory processes.

• The fine line between overregulation and innovation.

2. Digital Regulations: Europe vs. The Rest of the World

Different regions approach regulations in unique ways. Marion shares insights on:

• Europe’s data privacy-first approach (GDPR and AI Act).

• The US market-driven model, prioritizing fast innovation.

• China’s state-controlled regulatory framework and its impact on global competition.

• How small businesses are being pulled into compliance, whether they like it or not.

3. Atlassian Marketplace & Compliance Trends

With Atlassian tightening security requirements for Marketplace vendors, more partners need to think about ISO certifications, SOC 2 compliance, and customer data protection. Marion breaks down:

• What Atlassian’s new partner program means for vendors.

• How compliance will become a competitive advantage.

• How SoftComply’s Jira-integrated tools help companies stay ahead.

4. AI, Compliance, and the Future of Regulations

As AI continues to reshape industries, regulations are struggling to keep up. Marion discusses:

• The challenges of regulating AI in healthcare.

• Why AI models often contain biased data sets.

• The ethical dilemmas of using AI-driven diagnostics in underserved regions.

• The balance between deregulation for innovation vs. ensuring safety.

5. Making Compliance Work for Your Business

For many companies, compliance is a necessary evil. But Marion argues that it doesn’t have to be. Key takeaways include:

• Why compliance should start at the development stage, not after the fact.

• How integrating risk management into Jira can simplify the process.

• The importance of lean, agile compliance frameworks.

• Why compliance can be a strategic advantage, not just a checkbox.

Key Takeaways

• Compliance isn’t just about rules—it’s about safety and trust.

• Europe, the US, and China have different regulatory models, each shaping global business in unique ways.

• Atlassian vendors must start preparing for stricter compliance requirements.

• AI is creating new regulatory challenges, especially in healthcare.

• Lean, automated compliance tools like SoftComply’s apps can make compliance faster and easier.

Final Thoughts

The world of digital regulations is evolving fast, and businesses that ignore compliance do so at their own risk. Whether you’re an Atlassian Marketplace vendor, a MedTech startup, or just someone navigating corporate security requirements, understanding and embracing compliance will give you a competitive edge.

Listen to the full episode here: Apple Podcast | Spotify | Youtube

What’s your take on digital regulations? Share your thoughts in the comments.