Clinical Evaluation for Medical Device Software (MDSW)

Shine a light on your software’s clinical evaluation - without being overwhelmed 

Clinical evaluation for Medical Device Software (MDSW) or Software as a Medical Device (SaMD) is often where first-time manufacturers feel the most uncertainty. In this engaging podcast-style webinar, our experts Matthew Kirkman and Aleksander Kowalski cut through the complexity and show how to build a credible, rightsized evidence strategy for your device - so you can move forward with confidence.  

Why attend 

If you’re planning, developing, or maintaining an MDSW/SaMD product, you may leave with a clear understanding of which evidence routes fit your device and context, how to weigh pros and cons, and how to avoid common pitfalls that delay submissions and assessments. 

What you can learn 

• Performance route (Article 61(10)) - When and how this pathway applies to MDSW, and typical documentation expectations. 
• Equivalence route - How to define and justify equivalence for software, what comparators are acceptable, and where this approach is likely (and unlikely) to succeed. 
• Generating your own clinical data - What “sufficient clinical evidence” means in practice, leveraging real world data, and aligning your plan with risk, claims, and intended use.  
• Decision criteria for your organization - How product risk class, claims, available data, and timelines shape your optimal route - and what to do if your situation changes mid development.  

Key takeaways 

Choose the right evidence route, faster — Gain insights to plan your clinical evaluation strategy and decide between performance, equivalence, or generating clinical data based on your device’s claims, risks, and maturity.  

Justify your approach with confidence — Understand the documentation, rationale, and common reviewer questions for each route—so your CER stands up to scrutiny. 

Design evidence that scales — Build a clinical strategy that supports your first submission and adapts to new features, updates, and post market learnings. 

Meet the speakers

Matthew Kirkman 
Clinical Reviewer, TÜV SÜD Medical Health Services, France - Matthew is a seasoned Clinical Reviewer, specializing in evaluating clinical evidence for medical device software. He brings clear, practical insights into how reviewers assess performance claims, clinical data, and CER documentation under the MDR. 

Aleksander Kowalski 
Technical Documentation Assessor, TÜV SÜD Medical Health Services, Poland - Aleksander is an experienced Technical Documentation Assessor focused on MDR-compliant technical files for MDSW. He helps manufacturers strengthen documentation quality, ensure evidence aligns with claims, and avoid common submission pitfalls.  

Malte Knowles Schmidt (Moderator) 
Global Portfolio Manager SaMD, AI and Cybersecurity, TÜV SÜD Medical Health Services - Malte has worked as Product Leader with implantable cardiac devices and user-centric MDSW. In his role at TÜV SÜD, he is shaping the service portfolio for MDSW, AI, and Cybersecurity, ensuring these offerings are guided by real customer needs and deliver practical value to manufacturers.  


Reserve your spot to secure your place and get the recording, slides, and a practical checklist for MDSW clinical evaluation. 



Compliance note: The presenters will not be able to provide tailored advice about meeting the regulatory requirements for specific, named medical devices.