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

Widely regarded as the main contributors of the sharing of knowledge around medical device industry, Chris Gates and Axerl Wirth share their perspectives on what has changed in the past decade around medical device cybersecurity.

Thisepisode is agnostic of geography or legislation and includes learnings for all medical device engineers to get.

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/

The second part of the episode is coming out next week, folks. Can't wait to hear what you think of it!

Securely yours,

Cyber Doctor

Picking the right approach to look at risk is very important. Get it wrong and you're in for a denied submission.

MDR requires manufacturers to use the As Low as Possible Approach. And it ahs consequeces on the way we look at cybersecurity in general.

Our gest today is an all-around expert in medical devices. Tobor Zechmeister was a medical device entrepreneur, and now works as a consultant and an auditor in medical devices. His different perspectives make this episode unique in the angles of conversation it brings.

Through this episode you'll understand which method to choose to submit a device in Europe, how it differes from other risk management methodologies, and the implications it has on cyber as a whole.

Feel free to connect with us on our LinkedIn accounts:

https://www.linkedin.com/in/tibor-zechmeister/

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

Be sure to follow the podcast, we have some nice episodes coming, including a two part epsiode with the people I consider to be the Fathers of Medical Device Cybersecurity. Stay tuned.

Securely yours,

Cyber Doctor

There are somany standards for Medical Devices. Today we're taking a look at 2 of the most used in the cybersecurity space.

ISO 14971 is the main standard for managing risks in medical devices. It helps organizations find and control risks to improve device safety.

IEC 81001-5-1 focuses on managing cybersecurity risks in health software. It guides how to handle and reduce digital threats to medical IT systems.

Tune in to find out more on how these standards play against each other, and how you can use them to create safer medical devices that keep thriving on the market.

Securely yours,

Cyber Doctor

Can you imagine if we trusted that everyone who logs into a device? It would be chaotic. This is why we need to make sure the person logging in is indeed the person they say they are.

This is the process of authentication. And it's critical to get it right to ensure medical devices are protected.

Through this episode my ghuest and I talk about what it means to have a secure authentication process and what it looks like to implement a quality process in practice.

My guest Aaron Painter is a cybersecurity expert and CEO of Nametag Inc., where he develops advanced AI solutions to secure devices and prevent online impersonation and deepfakes. With a background in global tech leadership, Aaron specializes in protecting digital identities and making online interactions safer.

Feel free to connect with us on LinkedIn:https://linkedin.com/in/mathieupeteau/https://www.linkedin.com/in/aaronpainter/Aaron's company: https://getnametag.com/

Securely yours,

Cyber Doctor

The FDA is undergoing massive job cuts. Whether we like it or not, this will undoubtedly change the approval landscape of medical devices. And it already has.

My guest Etienne Nichols and I talk about the implications of these changes for Manufacturers and what they can do to remain competitive in this evolving landscape.

Etienne Nichols is an all around talent in Medical Devices. He started as a mechanical engineer and is now leading the community of Greenlight Guru with his podcast: the Gobal Medical Device Podcast. On it he welcomes guiests of all fields to share their knowledge on making better devices.

More ways to reach us:

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

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

I have a newsletter with weekly tips on improving emdical device cybersecurity. You can find it here: http:// cyberdoctornotes.com

Episode timestamps:

00:00 FDA dismissals

01:51 About Etienne Nichols

04:09 Dismissal implications

07:28 Making better submissions

13:31 Improving Q&R

18:18 Predictions on submissions

21:12 MEDUFA

26:01 Secrecy in Medical Devices

28:48 AI for submissions

31:51 Best MDMs do this

Any questions or feedback I'm very happy to hear your thoughts: [email protected]

Securely yours,

Cyber Doctor

Healthcare institutions are the ones buying the medical device, ultimately. Yet, we don't often talk about their cybersecurity demands.

Our guest Christopher Frenz has spent most of his career protecting hospitals from cyber attacks. And it's not an easy task. While the landscape evolves every month, medical devices often stay the same for years, if not decade. How do these challenges manifest themselves? And what can a medical device manufacturer do about them?

Christopher is the author of many influential publications such as the OWASP Secure Medical Device Deployment Standard, the OWASP Anti-Ransomware Guide, and most recently the CSA Medical Device Incident Response Playbook.

Join me on this reality-check conversation where we dive into the other side of the medical device.

Securely yours,

Cyber Doctor

Today we're tackling some of the biggest questions around the EU regulations landscape in cybersecurity of medical devices.

Our guest is Elisabetta Biasin, a legal researcher specializing in cybersecurity, AI regulation, and EU laws. Elisabetta provides critical insights into the complex regulatory landscape facing medical device manufacturers implementing AI in Europe. She expertly breaks down how multiple frameworks—including the AI Act, MDR, NIS2, and GDPR—overlap and create compliance challenges, explains the specific cybersecurity requirements for AI systems under Article 15, and clarifies how data protection requirements extend beyond just personal data.

With real-world examples of potential cybersecurity vulnerabilities in medical devices like pacemakers, this episode delivers essential knowledge for manufacturers navigating the evolving European regulatory environment.

Want weekly actionable advice on medical device cybersecurity from yours truly? go here -> http://cyberdoctornotes.com

Elisabetta's profile:

https://mastodon.social/@[email protected]

https://www.linkedin.com/in/elisabetta-biasin-550a4711a/

[email protected]

Please share with a friend & rate the show 💚

Securely yours,

Cyber Doctor