Automating Compliance with AI in the MedTech SDLC

Injecting Compliance into Code: Automating Compliance with AI in the MedTech SDLC

Randy Horton

Published on: June 1st, 2026

Is your highest-paid talent stuck in a compliance trap? Your engineers should be writing code (or leveraging AI to write code), not manually generating design control documentation and traceability matrices.

When teams are pulled into repetitive compliance work, development slows. As system complexity increases, manual processes delay feedback, introduce risk, and make it harder to maintain both speed and quality.

This webinar explores how automation can be built directly into the development life cycle so compliance, testing, and resilience become part of how software is created. Instead of treating documentation and quality as separate activities, teams can make them automatic outputs of the development process. It also examines how AI is used in the SDLC to complement automation and drive further productivity gains.

Join Orthogonal to learn how an automated, well-functioning SDLC changes how MedTech, SaMD, and connected device teams build, validate, and scale software under design controls.

What You’ll Learn

Automate Compliance Documentation – Transform human- and machine-readable code (like Gherkin) into validated compliance artifacts.
Improve SDLC Efficiency – See how an automated SDLC can deliver an initial 50% productivity boost, with potential to double efficiency over time.
Implement Continuous Quality – Apply TDD and BDD to create fast feedback loops that catch errors early.
Build System Resilience – Enable system modules to communicate failure modes and mitigate risk.
Manage BYOD Testing at Scale – Apply a risk-mitigating strategy for handling continuous changes across modern mobile platforms and devices.
Leverage AI within SDLC – Incorporate AI alongside automation to further improve speed and quality across development

Who Should Attend?

Executive & Business Leaders looking to reduce wasted R&D investment and eliminate compliance bottlenecks.
Product, Engineering & R&D Teams building SaMD or connected devices who need to accelerate release cycles without sacrificing quality.
Quality & Regulatory Leaders focused on embedding compliance directly into modern software workflows and reducing cross-functional friction.

If manual compliance work is slowing your ability to scale software-enabled medical products, this session offers a practical path to automate that overhead.

Save Your Seat

Larkin Lowrey, Senior Director of Software Engineering for Digital Health, Tandem Diabetes

Randy Horton, VP of Solutions and Partnerships, Orthogonal