Event Recap: HFE Regulatory Session II

On October 16, the second edition of the Health Founders Estonia Regulatory Sessions took place, attracting nearly 70 participants from MedTech start-ups and scale-ups working on MDR/IVDR compliance, as well as public sector representatives and ecosystem stakeholders involved in healthcare regulation, certification, or supporting MedTech innovation, both on-site and online. Aimed at helping founders turn regulatory complexity into clarity, the session offered practical insights, expert guidance, and peer-learning opportunities to accelerate compliance readiness.

📍 Explore the recording and materials shared at the event here.

Turning Regulation into a Strategic Advantage

At Health Founders Estonia, we believe that progress in health innovation happens when founders learn directly from other practitioners: those who have faced the same regulatory hurdles and turned them into strengths. Our Regulatory Session II once again brought this philosophy to life.

The agenda combined expert presentations, interactive sparring, 1:1 office hours, open discussions, and networking, ensuring that participants could apply lessons directly to their own regulatory journey.

Our speaker, Matthew DiFranco, with 15 years of experience in the healthtech sector, set the tone with a clear message about the value of understanding regulations early.

“Regulatory requirements for medical devices can seem complicated and overwhelming to newcomers in MedTech. Many founders and start-up teams view them as a roadblock to innovation, something to get around rather than the guardrails and signposts that guide them. Setting up your quality management system and understanding how to develop a regulatory strategy is a critical step in bringing MedTech innovations into use for the benefit of hospitals, clinicians, and patients.”

Key Topics Covered

The session addressed several crucial areas of regulatory readiness, on topics such as:

• Introduction and critical aspects of QMS under MDR/IVDR
• Practical implementation considerations for QMS (ISO 13485) and risk management (ISO 14971)
• Technical documentation and audit readiness

Through this blend of structured content and open discussion, founders gained clarity on how to incorporate compliance principles into their operations from the beginning by turning regulatory planning into a foundation for sustainable growth.

Founder Perspective: Learning from Real-World Experience

Adding a real-world dimension, Helena Ije, COO at Better Medicine, shared her company’s journey to CE marking and the lessons learned along the way.

“Getting CE marking was a massive milestone for us, but the real takeaway is that you shouldn’t wait too long to think about regulations. If you push compliance aside, it can quickly turn into a very expensive blocker. Embedding quality and regulatory thinking into your culture early — rather than treating it as a side project — makes all the difference later. It’s not a box-ticking exercise; it’s part of how you build a product that lasts.”

A Stronger Ecosystem Through Shared Learning

By combining expert insight with founder experience, the Regulatory Session II reinforced a key principle of the Health Founders Estonia community: when founders learn from founders, innovation accelerates. These peer-led exchanges don’t just help companies achieve compliance; they build stronger, more resilient MedTech ventures capable of scaling safely and sustainably.

The HFE program is funded by the EU through Enterprise Estonia, in collaboration with Startup Estonia, to build a strong, globally competitive health tech ecosystem in Estonia.