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Agentic AI for MedTech
Agentic AI Resources for Regulated MedTech Teams
Explore Orthogonal's articles, webinars, playbooks, and practical guidance on applying Agentic AI in regulated MedTech software development.
Agentic AI describes multi-agent systems that can plan, reason and carry out product-development tasks, rather than simply completing text or code. In MedTech that means agents helping to generate requirements, draft user flows, write and test software, and produce the documentation that supports a regulated product.
The effect is felt across the lifecycle. Requirements become the contract an agent works against, so intended use, data boundaries and acceptance criteria have to be defined before a capability is built. Engineering shifts from writing every line of code to defining the constraints that govern how code is generated. Testing moves toward behavioral contracts that can be checked automatically as work proceeds. Quality and compliance work changes from assembling evidence at the end to maintaining it continuously, with traceability across requirements, risks, tests and documentation kept current rather than reconstructed before a submission.
What does not change is accountability. Decisions about architecture, clinical context, acceptable risk, and whether a product is safe and effective remain with engineers, quality professionals and clinical experts. Agent output is reviewed before it moves further through the lifecycle, and human judgment matters more in an agentic environment, not less.
This hub collects Orthogonal's practical guidance for regulated MedTech teams adopting these methods: how roles change, how compliance can become a continuous output of development, and how agentic workflows connect product intent to tested software.
Featured Resources
Agentic AI Playbook: How MedTech Teams Must Evolve
A role-by-role framework for engineering, product, SDET, quality and leadership teams moving from manual artifact generation to AI orchestration.
Agentic AI for MedTech: From Requirements to Tested Software
A recorded webinar showing how an agent can produce acceptance criteria, build software from them, and test whether the resulting behavior matches the original intent.
Automating Compliance with AI in the MedTech SDLC
How compliance, testing and traceability can become continuous outputs of development instead of a separate phase before submission.
AI-Enabled Medical Device Software Development Services
How Orthogonal designs, builds and validates AI-enabled medical device software under full design controls.
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