Medical Device Software: From Regulation to Ready for Market

Join us for an immersive, fullday workshop exploring the latest regulatory expectations, proven implementation strategies, and realworld case studies for softwaredriven medical devices under the EU MDR and FDA frameworks.   

📅 Date: 23 June  2026 
🕘 Time: 09:00 – 17:15 
📍 Location: Planegg/Munich, Germany 
💬 Language: English 
💶 Participation Fee: €250 
  
 

Who should attend? 

This workshop is ideal for organisations developing: 

• Software-driven medical devices
• Software as a Medical Device (SaMD)
• AI-enabled medical solutions 

It equips QA, RA, R&D, and software teams with practical insights they can apply immediately to strengthen compliance and support successful market access 

Why Attend? 

Developing software for medical devices involves navigating complex and rapidly evolving regulatory expectations under the EU MDR and FDA. This workshop is designed for medical device companies developing software that need practical, defensible, and audit-ready implementation. 

Participants will, through expert-led, real-world sessions: 

Gain clarity on software classification, including:  

• Medical device software 
• Wellness software 
• Borderline products 
• Learn how to implement IEC 62304 effectively across the full software lifecycle 

Understand regulatory expectations for key topics such as:  

• AI use in regulatory documentation 
• Cybersecurity and threat modelling
• Software Bill of Materials (SBOM) 
• AI and machine learning risk 
• End-to-end software traceability 

The workshop focuses on what regulators assess during audits and technical documentation reviews, helping teams to: 

• Reduce audit findings 
• Avoid common compliance pitfalls 
• Accelerate time to market 

With a hands-on, end-to-end approach, participants are guided through: 

• Intended use and user needs 
• System and software requirements 
• Development and risk management 
• Verification, validation, and post market considerations 

The programme is enhanced by: 

• One-to-one sessions with experienced regulatory and software experts 
• Tailored, actionable guidance for specific products and challenges. 

More details and the full agenda will be shared soon — we look forward to welcoming you in Munich!