Tandem Health becomes the first AI medical scribe company to achieve ISO 13485 certification

‍Raising the bar for trust, quality, and safety in clinical AI.

We’re proud to share that Tandem Health has achieved ISO 13485:2016 certification, the global standard for quality management systems for medical devices.

This certification recognises our continued commitment to building AI tools that meet the highest standards of safety, reliability, and regulatory compliance in healthcare.

What ISO 13485 means for clinicians and patient safety

AI in healthcare is moving fast, but trust moves slower (and rightly so).

Clinicians deserve tools that are not only helpful but rigorously tested and built to the same standards as medical devices they already rely on.

By achieving ISO 13485 certification, Tandem Health becomes the first company in our category to meet these standards for software medical devices used in clinical documentation.

This means our design, development, and operational processes are independently verified to comply with the strictest global requirements for quality, risk management, and traceability.

What this certification means in practice

Our certification applies to:

"Design and manufacture of Software Medical Devices for documentation management to support healthcare professionals with clinical documentation and related administrative tasks."

In simple terms: it validates that every part of how we build Tandem—from code to compliance—follows a structured, audited quality process.

Embedding quality and safety in every line of code

We don’t see quality and safety as something to tick off a list. They’re built into everything we create because trust starts there.

AI tools are increasingly involved in the clinical workflow. That comes with responsibility to protect patient data, ensure accuracy, and support clinicians safely.

ISO 13485 helps us do that by embedding quality control and continuous improvement into everything we do.

Setting a new benchmark for responsible AI in healthcare

Healthcare is built on standards.

AI in healthcare should be no different.

By aligning Tandem with the same medical device framework that hospitals, regulators, and manufacturers already trust, we’re helping to define a safer, more accountable path forward for clinical AI.