Some time ago, I received a collaboration request from a well-known Finnish software company offering software developer resourcing services. They wanted to know how to healthcare-certify software developers.

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It’s an understandable question—the need to determine how to qualify and evaluate developers in the MedTech industry is real. For startups, building a quality management system (QMS) always starts from scratch: introducing a new QMS and developing software according to a new process. This situation is like handing a skilled aerobatic pilot a stack of instructions and asking them to fly a jumbo jet. It might work, but for it to be smooth and efficient, it still takes time.

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Even established software companies with existing medical products are struggling. With the EU’s Medical Device Regulation (MDR) now in effect, many Class I software products are being reclassified into higher risk classes. This change requires manufacturers to submit their documentation to a notified body for inspection. These bodies use standards as inspection tools, reviewing them line by line before granting the CE mark to the software device.

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It’s clear that healthcare digitalization demands skilled developers—those with both expertise and experience in the regulated medical device environment. These developers are essential for getting projects off the ground and into production smoothly.

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Returning to the company’s original question about certified developers: the truth is, there’s no such thing, and that’s exactly what I told them. There is no authorized body that certifies a software developer’s skills and experience according to, for example, IEC 62304. That standard defines a software lifecycle process—it’s not a developer-specific certification. Regulations focus on the device itself: its safety, traceability, and how the software is tested to ensure quality.

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At Innokas, we operate under ISO 13485-certified processes. As part of our standard onboarding, every developer is introduced to our ISO 13485-compliant quality management system and participates in risk management training. Since autumn 2021, we’ve also been developing an internal “Developer IEC 62304 Hands-On” training program—created by developers, for developers—with strong support from our regulatory experts.

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Even our most senior new hires, with 15+ years of software development experience, join projects where they are mentored and supported by experienced medical software professionals.

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By the time they’re fully onboarded, our Innokas software team and developers have:

✅ ISO 13485 – check

✅ ISO 14971 – check

✅ IEC 62304 in practice – check

✅ Medical experience – check

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