^{Published on 27.1.2026}

In medical device development, reaching the finish line of certification should feel like a moment of triumph, but for many companies, the final stages of review and compliance testing reveal critical gaps that delay or even derail market entry. As our recent discussion highlighted, the root causes are often surprisingly consistent.

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The usual suspects keeping medical devices from being certified

What are the most common reasons for failing certification? According to Lassi Oikarinen, who has over 15 years of experience designing electrical devices under IEC 60601‑1 and IEC 61010‑1, the same culprits surface more often than others: EMC issues, incorrect or incomplete labeling, and electrical safety non‑compliances. These are all areas where applicable standards provide extremely clear expectations – if teams know how to use them.

And that’s the heart of the matter. Following the right standards from the start is the easiest and most reliable way to pass a Notified Body review. While standards are not legal requirements, they represent state-of-the-art safety expectations and offer a clear, recognized path for demonstrating product conformity. In other words, they give developers a structured way to speak the same language as reviewers; a way to demonstrate that your device is designed with safety in mind.

Teams must understand these details about the device when they begin:

• Intended use

• Market region

• Operating environment

These factors define which standards apply. Without this foundation, even the best engineering work may fall out of alignment with regulatory expectations.

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Why standards alone aren’t enough

But simply compiling a list of standards isn’t enough. As Lassi noted, the standard list alone doesn’t define the full safety requirements. To interpret standards correctly, developers must pair them with a product‑specific risk analysis and a clear definition of essential performance. IEC 60601‑1 alone refers to risk analysis more than 80 times, so it's evident of how deeply intertwined these processes are. A test such as a drop test, for example, is not simply “pass or fail”. It passes if it does not introduce an unacceptable risk to the patient.

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Don’t forget usability and biocompatibility

On top of that, real user needs and technical requirements must complement the standards and risk analysis to form a complete set of design inputs. And the work doesn’t stop there: usability and biocompatibility evaluations also play essential roles in ensuring a device is safe, effective, and ready for its target environment.

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Video: Why usability matters in medical device development?

Reduce last-minute surprises with pre compliance testing

Before facing the official compliance tests, teams can greatly reduce risk by performing preliminary standard compliance checks, especially for EMC, where many of the most common failures occur. Early insights significantly reduce the risk of unexpected nonconformities during the official tests.

A well-designed product deserves complete verification, and that's why Innokas offers the capability to support electrical safety testing as part of the product development process. A device that is engineered with care should never be left wanting at the final certification stage. If you could use support in this area, reach out to us via the link below and we will get back to you shortly.