Medical device software

Medical device software testing

Medical device software testing is the shortest path in this map, and the honest reason is that most of what this kind of product needs is not a laboratory test at all.

Software that is itself the medical product: an app, a program or a cloud service, with no hardware of its own. The industry calls this software as a medical device.

This is a map of what testing a product class commonly needs. It is not regulatory advice, and it does not replace your own risk analysis or a notified body's view.

What the terms on this page mean

MDR:: the EU Medical Device Regulation, the law a medical device must satisfy to be sold in the EU.
RED:: the EU Radio Equipment Directive, the law that applies on top of the MDR as soon as your product contains a radio such as Bluetooth or Wi-Fi.
Harmonised:: a standard named on the EU's official list. Testing to it earns presumption of conformity, meaning the authorities accept it as proof without further argument.
Accredited scope:: the exact list of tests a laboratory has been independently assessed to perform, published by its national accreditation body.

Tell us about your product

These are the answers that change which testing applies. Everything below stays on the page either way; turning an answer off only fades the categories it triggers.

1 answer turned off. The categories they trigger are faded, not removed.

What medical device software testing may involve

2 laboratory categories. The laboratory counts below were taken from our register on 2026-08-18.

C11

Software lifecycle and cybersecurity assessment

Assessment of the software lifecycle, the safety classification, and security work. Mostly a review activity rather than a bench test.

If the product is software, this may require software lifecycle and cybersecurity assessment.

This is the only category that always applies when the software is itself the medical product.

IEC 62304Not harmonised under the MDR
Lifecycle requirements for medical device software, including the safety classification.
Universally applied, universally expected, and not harmonised under the MDR. Most of the work is assessment rather than bench testing, which is why few laboratories hold it in an accredited scope.
Why? S052
Consolidated MDR harmonised-standards list, Implementing Decision (EU) 2021/1182 as amended, CELEX 02021D1182-20260617: absence re-verified 2026-08-17

26 laboratories in our register reference IEC 62304 in their published scope text (counted 2026-08-18). Search the register

A laboratory can hold capability that its published scope text does not itemize. Absence from these counts is not evidence of absence.

C09

Usability engineering and human factors evaluation

Formative and summative evaluation with representative users, use-error analysis, and evidence that the interface does not induce harm.

If clinical decisions are taken from the interface, this may require usability engineering and human factors evaluation.

A misread screen is the entire hazard surface of a software device.

IEC 62366-1Not harmonised under the MDR
The usability engineering process: formative and summative evaluation with representative users, and evidence that the interface does not induce harm.
The named usability standard for medical devices is not harmonised under the MDR, which surprises most buyers.
Why? S048
Consolidated MDR harmonised-standards list, Implementing Decision (EU) 2021/1182 as amended, CELEX 02021D1182-20260617: absence re-verified 2026-08-17

29 laboratories in our register reference IEC 62366-1 in their published scope text (counted 2026-08-18). Search the register

A laboratory can hold capability that its published scope text does not itemize. Absence from these counts is not evidence of absence.

What does not apply, and what we cannot yet tell you

These are statements about the regulation or about our own map. They are not advice, and they carry no status colour because nothing here was verified about your product.

Algorithm performance is not a lab-testable category

Software that is itself the medical product has no accredited laboratory test for how well its algorithm performs. This is not something a laboratory can test; the evidence comes from your own clinical evaluation and software lifecycle process, not from a test report.

Electromagnetic compatibility does not apply to software on its own

IEC 60601-1-2 applies to medical electrical equipment, not to software. Software running on a user's own phone or computer carries no EMC obligation of its own. It returns only if you supply dedicated hardware with the software.

Why? R054

IEC 60601-1-2 scope: medical electrical equipment and systems

Next step

Each card above links to the laboratories in our register that hold that standard. If you would rather describe the job in your own words, ask for a recommendation, or go back to the other product types.