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 imp...
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 ...
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 con...
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 ...
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 conse...
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 help...
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 proce...
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 ...
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 prot...
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 cyber...
I think you understand how important it is to protect medical devices. But what about the organization that makes the medical device?Well, it has its own security requirements. European legislation su...
There's hundreds of tasks to do before releasing a medical device. What if we could make one of them fun all while being more productive?That's the idea that our guest Christoph Niehoff expanded upon....
Medical Devices need patching. Whether it's for functionality or security, devices must be able to be updated remotely.But what about those devices that you cannot patch?What are some things manuf...
Why reinvent the wheel? Industry-leading experts have already paved the way for medical device security. By following established good practices, you can ensure the safety and integrity of your device...
CISA and the FBI have released a report guiding Medical Device Manufacturers on how to code their devices securely.At the top of the priority list is a new recommendation to phase out the use of C and...
Medical Devices are getting increasingly complex.We're now dealing with interconnected medical devices with tens of inputs, dozens of connections, and a plethora of connections. How can you handle sec...
Everyone knows cybersecurity in medical devices is important. But how many knowhow to make secure devices?Our two guests Jose Bohorquez and Mohamad Foustok are packed of experience in building medical...
To get us started on this journey, I invited one of the most influential medical device patients in the cybersecurity space. Veronica "Vee" Schmitt is an advocate for cybersecurity in medica...
Hi Folks! This introduction episode is to present the Medical Device Cybersecurity Podcast and myself, your holt, Mathieu “Cyber Doctor” Peteau.
Since this episode might be the only one that focuses o...