ISO 62304 (Medical Device Software Development) Verification Requirements

Hi,
i would like your opinion on the following situation:

A company develops a medical SW which is class A according to ISO 62304.

The company does what i would call "black box testing" of the SW:
It clicks through all functionalities of the SW. They do that according to a plan and have defined acceptance criteria.

There is no unit testing and no integration testing.
there is no code review.

Risk management comes to the conclusion, when analysing the functionalities, that the system can cause no harm to the patient (class A)

Questions:
1) Does the testing comply with ISO 62304?
2) Does the testing sufficiently challenge the System ?,
3) Does the testing fulfill the essential requirements of the MDD: "to develop and validate according to the state of the art" (He does further validation of the use, i really look for the verification part)

I use "Testing" synonymously (i had to spell check that word, but it seems to really exist) for SW-verification.

thank you for your feedback.
(Yes, the quality system is under ISO 13485, and the SW is going to be CE marked under the directive 93/42)

Hi,

1) Does the testing comply with ISO 62304?

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Lets review what are we talking about.

5.1.1 Software development plan

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So, first it complies in case there is an overall development plan defining the verification activity.

5.2.6 Verify software requirements
The MANUFACTURER shall verify and document that the software requirements:
a) implement SYSTEM requirements including those relating to RISK CONTROL;
b) do not contradict one another;
c) are expressed in terms that avoid ambiguity;
d) are stated in terms that permit establishment of test criteria and performance of tests to
determine whether the test criteria have been met;
e) can be uniquely identified; and
f) are traceable to SYSTEM requirements or other source.

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So, second it complies when there is a test case collection with acceptance criteria tracking back to System Requirements with distinguished attention on risk mitigation requirements , there is a detailed test plan based on the SW development plan and on the test case sets, there is a test execution report and there is a test summary report.

2) Does the testing sufficiently challenge the System ?

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Well, surely yes, as long as you have a test set library (test case collection if you like) covering all system level requirements.

3) Does the testing fulfill the essential requirements of the MDD: "to develop and validate according to the state of the art" (He does further validation of the use, i really look for the verification part)

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For verification yes, 62304 is a harmonized standard.

One more think, for Risk Management you shall follow ISO14971, it is a normative reference standard (you MUST follow) in 62304.

br
Sz.