SaMD Development and the Use of AI Tooling

Randy Horton
Randy Horton
Published on: October 21st, 2025
Nov 2025 Webinar Banner Post

While much attention has been given to AI-enabled medical devices, this session explores something equally important: How AI is embedded within the tools developers use to build those devices.

AI tooling is changing how medical device software is developed. But when these tools are used in regulated environments, safety, validation, and compliance become critical, and a new set of related (and interesting) challenges arises.

Orthogonal and SoftComply co-hosted a focused conversation about using AI tools responsibly in the development of SaMD and other medical device software.

Our experts explained how FDA and MDR guidance apply to AI-powered development tools, what risk and validation challenges they introduce, and how teams can adopt them safely without slowing innovation.

Watch Webinar Recording
Marion Lepmets

CEO & Co-Founder, SoftComply

Marion Lepmets

Dr. Marion Lepmets is CEO & Co-Founder of SoftComply, an Atlassian Gold Partner providing risk and document management tools for Jira and Confluence Cloud. She helps regulated companies automate compliance. A co-author of IEC TR 80002-3 & contributor to IEC 62304, she holds a PhD in Software Engineering & mentors MedTech startups through EIT Health and Startup Creasphere.

Matteo Gubellini

Co-Founder & Chief Regulatory Officer, SoftComply

Matteo Gubellini

Matteo Gubellini is Co-Founder and Chief Regulatory Officer of SoftComply, ensuring its tools meet U.S. and EU medical device regulations. A mechanical engineer with over 20 years in MedTech, he specializes in risk management, design assurance, and cybersecurity. Before founding SoftComply in 2016, he held senior roles at Mallinckrodt, BlueBridge Technologies, and Stryker.

Bernhard Kappe

Founder & CEO, Orthogonal

Bernhard Kappe

Bernhard Kappe is Founder and CEO of Orthogonal. For over a decade, he’s led innovation in SaMD, DTx, and connected medical devices. He authored Agile in an FDA Regulated Environment and co-authored AAMI’s cloud computing report. A Penn and Wharton grad, he founded ChiPMA and the Chicago Lean Startup Challenge, helping MedTech firms advance impactful software.

Randy Horton, VP of Solutions and Partnerships, Orthogonal

Chief Solutions Officer, Orthogonal

Randy Horton

Randy Horton is Chief Solutions Officer at Orthogonal, helping MedTech firms speed development of SaMD, digital therapeutics, and connected devices through modern software practices and regulatory rigor. He co-chairs AAMI’s Cloud Computing Working Group and contributes to AAMI CR:510(2021) and TIR #115. Horton is also a frequent speaker at AdvaMed, AAMI, HLTH, RAPS, and HFES events.

Related Posts

Talk

SaMD, Digital Ecosystems and the New Rules for Cybersecurity

Talk

Medical Device Manufacturers as Providers: A New and Emerging MedTech Model

Talk

Leveraging Automation to Deliver High-Quality MedTech Software

Talk

The Playbook for Running a Multi-Partner Engineering Organization

Back to Insights
BSI ISO 13485 Logo
Terms of Use | Privacy Policy | Careers
All Rights Reserved © 2025 Orthogonal