Season 1 has been filled with wonderful conversations. I feel like I've learned so much about medical devices, cybersecurity, and entrepreneurship as a whole. Today we listen again to the most impactful moments from our conversations.

I also reflect on what these extract meant to me and what it means for you as a medical device manufacturer.

It's been awesome sharing my passion for medical device cybersecurity with you for a season! Thanks for being part of the journey.

Securely yours,

Cyber Doctor

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!

Securely your,

Cyber Doctor

We're back for part 2!

In this one we dive deeper in the topic of what it's like to lead cybersecurity at a hospital, the specifications that Manufacturers look for, and take a deeper dive into the controversial questions around cybersecurity.

Axel and Chist wrote a book together called Medical Device Cybersecurity for Engineers and Manufacturers, and recently published their second edition. If you'd like to buy it,, they've share their disount code that's available to use on the publisher's website.

⁠Website⁠

Code: WIRTH25

More ways to follow:

⁠https://www.linkedin.com/in/mathieupeteau/⁠

⁠https://www.linkedin.com/in/axelwirth/⁠

⁠https://www.linkedin.com/in/christopher-w-gates/

We're neating the end of the season with one more episode coming. After that we'll do a recap of all the learnings I've had in the 17 first episodes of the series. Be sure to subscibe/follow to be on the loop.

Securely yours,

Cyber Doctor