Quality and regulatory work for software and AI-enabled devices
I work with software as a medical device and devices with software, including AI-enabled devices, under IEC 62304, IEC 82304-1, EU MDR and the EU AI Act. Cybersecurity is outside my scope.
Three situations where this works best
You build software as a medical device and need a quality system and a route to market that fit how software is developed.
The software life cycle needs to comply with IEC 62304, alongside the rest of the device.
AI-enabled functions bring requirements from EU MDR, the EU AI Act and the FDA that have to work together.
Your product is software
Your device runs on software
Your device uses AI
Your development team works in sprints, and the quality system doesn't reflect it.
You are not sure whether your software qualifies as a medical device.
You need to set the software safety class under IEC 62304.
Your device includes an AI model, and you need to understand what the EU AI Act adds.
A notified body or the FDA asked questions about your software documentation.
You probably need this if one of these sounds familiar
Software quality that fits how your team works
Processes under IEC 62304 that work with the way your developers already work.
Qualification, classification and the requirements of each market.
The EU AI Act and AI-specific requirements built into the quality system and the technical file.
Cybersecurity is outside my scope. When the project needs it, I bring in a specialist you approve in advance.
A software lifecycle that fits your team
A route to market for software
AI handled within the system
Clear boundaries
From a first conversation to the work itself
You tell me about the device, the market you are aiming for and your timelines. I tell you what I would do first.
When needed, I go through your procedures, your technical file or your most recent audit reports.
The scope of work, estimated hours and a timeline. I work by the hour.
I work with your team on what the company needs at that stage, and we meet regularly for updates.
A first conversation
Looking at what you have
A clear proposal
The work itself
A company whose entire product is software built on AI came to me without a quality system. I'm building one with them that fits the way a software team works, with the IEC 62304 software development lifecycle at its center and the requirements for AI-based devices built in from the start.
Software only, built on AI
Yes. I work with software as a medical device and devices with software, including AI-enabled devices, under IEC 62304, IEC 82304-1, EU MDR and the EU AI Act. Cybersecurity is outside my scope.
No. I don't take on the PRRC role under EU MDR Article 15 as an outside person. I work with the PRRC you appoint and make sure they have what they need to do the job.
Yes, with control. I help you write the procedure for using AI, validate the tools you use and train your team, so the AI supports your work without creating new risks.
Do you work with software and AI-based medical devices?
Can you serve as our PRRC?
Can we use AI tools in our quality system?
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A 30-minute call. You tell me where you are, I tell you what I'd do first and whether I'm the right fit.