Medical Device Software Regulation: successful MDR certification and how to prepare for it

Join us for an engaging, podcast-style on-demand webinar where our team of experts brings you the latest in Medical Device Software Regulation. This isn’t just another technical session - our goal is to connect with you as peers, share our experiences, and help you navigate the complexities of MDR certification and regulatory requirements. 

Meet the Experts 

Our panel features seasoned professionals - Marco Caproni, Aleksander Kowalski, Trisha Punj, and moderator Malte Knowles Schmidt - who will introduce themselves not just by their credentials, but through personal stories and relatable anecdotes. Discover what inspired them, the first software they ever used, and how their unique backgrounds shape their approach to medical device innovation.  

What You’ll Experience 

A Conversation, not a lecture: The on-demand webinar is structured as a lively interview and open discussion. You’ll hear candid insights, practical advice, and real-world stories about what works - and what doesn’t - in medical device software regulation. 

Interactive Format: Ask questions live, participate in chat discussions, and help us shape future webinars by sharing your feedback through quick polls. 

Actionable Takeaways: Each expert will tackle a key topic - foundational aspects, documentation, cybersecurity, and AI - offering tips, common pitfalls, and success stories you can apply in your own work.  

Why Attend? 

• Build Trust: See how our experts relate to your challenges and understand your company’s situation. 
• Get Practical Answers: Learn how to avoid common mistakes, balance innovation with compliance, and address the latest regulatory demands. 
• Shape the Future: Your feedback matters! Help us refine our format and ensure our webinars deliver the value you need.  

Register Now 

Be part of a community that’s driving innovation in medical device software regulation. Reserve your spot! 

about the Speakers

Malte Knowles Schmidt (host)
Global Portfolio Manager SaMD, AI and Cybersecurity, TÜV SÜD

Malte has worked in various roles across the healthcare industry, working with implantable cardiac devices and later moving into user-centric MDSW development within corporate venture labs. Since April 2024, he has been with TÜV SÜD, shaping the service portfolio for MDSW, AI, and Cybersecurity, ensuring these offerings are guided by real customer needs and deliver practical value to manufacturers.

Aleksander Kowalski
Technical Documentation Assessor at TÜV SÜD Polska Sp. z o.o., specialized in the assessment of software and AI medical devices. Deputy Senior Product Specialist for Cybersecurity, TÜV SÜD

Over 10 years of experience in the development of medical device software approved for the European (CE) and American (FDA 510(k)) markets, covering the complete software development lifecycle: design, development, implementation, verification and validation, integration with hardware devices, infrastructure. Seasoned team, process, and product scope manager with extensive experience in agile development methods. 

Trija Punj
Principal Engineer, AI Software Assessor, TÜV SÜD

Trisha Punj is a Principal Engineer, AI Software Assessor at TÜV SÜD, bringing over 10 years of experience in artificial intelligence and software development. Her expertise lies in assessing AI-enabled medical technologies for compliance with the EU Medical Device Regulation (MDR), with a focus on Software as a Medical Device (SaMD). 
Trisha specializes in AI risk management, quality management, ethics, and regulatory frameworks. She is deeply involved in evaluating the safety, performance, and security of AI systems in healthcare, ensuring they meet stringent international standards.

Marco Caproni
Global Director SW Product Assessment , TÜV SÜD

Marco Caproni joined TÜV SÜD in 2018 as Product Specialist for active medical devices and he is the Senior Product Specialist for Software and AI. He is subject matter expert for all software-related products, including artificial intelligence technologies. He is also Global Director for Software Product Assessment team, leading the software, cybersecurity and AI experts in TÜV SÜD for medical devices and IVDs. In these roles, he leads comprehensive technical assessments, develops regulatory strategies, and authors guidance documents in alignment with the MDR/IVDR and relevant state-of-the-art standards. He has 15+ years of professional experience in the design and development of medical devices, in the area of software, extracorporeal circulation devices (such as dialysis) and has worked as software- and active medical devices-focused certification Lead Auditor and Technical Documentation Assessor.