AI is everywhere in Medical Devices. How do you manage documentation around them?

In this episode we are crossing the themes of documentation process and cybersecurity for AI-driven medical devices.

We answer questions like:

- What documentation process is expected from thr FDA and the EU's NBs?

- How to collaborate to build effective documentation?

- How to manage documentation debt?

Richie Christian is a seasoned medical device consultant with over a decade of experience in regulatory affairs, quality management, and market access for digital health technologies, including AI/ML-enabled software as a medical device (SaMD).

With a Master’s in neurophysiology from the University of Auckland and additional training in drug commercialization from UC San Diego, he has led regulatory initiatives at companies like Formus Labs, Aroa Biosurgery, and Fisher & Paykel Healthcare.

Now based in Switzerland, Richie advises MedTech firms at wega Informatik, helping them navigate regulatory pathways and implement robust quality systems for innovative healthcare software.

Thanks for listening, folks!

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