Penetration testing has been a cornerstone of medical device security for years. Regulatory expectations have outgrown the report-centric model. A single point-in-time test cannot demonstrate the thing regulators now ask for, which is completeness and traceability across the whole product, not a snapshot of whatever a tester happened to reach that week.
This is not a knock on penetration testing. Human-driven testing is still essential. It has to be repositioned as a targeted validation activity inside a broader, test-case-driven framework that ties findings to architecture and security controls, with evidence of execution and a full history across releases.
Senior testers are expensive. Expanding manual testing to the level of completeness a medical device needs, on every release, forever, is not economically viable. Postmarket makes it worse, because testing is expected to recur. The math does not work with people alone.
To show diligence now, manufacturers are expected to provide a complete inventory of test cases, traceability to architecture and controls, evidence of execution with pass or fail criteria, and a full history of what was found and fixed across development. That is a systems problem, not a report.
The question is not whether you tested. It is whether you can show what you covered, what you did not, and why.
The programs that hold up under review treat the security testing function as software that lives where the device is built and produces verdicts with evidence. The pentest becomes one input, not the whole story.
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Not on its own. A single point-in-time test cannot demonstrate what regulators now ask for, which is completeness and traceability across the whole product rather than a snapshot of whatever a tester happened to reach that week. The report describes an engagement. The regulator is asking about the product.
To show diligence, manufacturers are expected to provide a complete inventory of test cases, traceability to architecture and security controls, evidence of execution with pass or fail criteria, and a full history of what was found and fixed across development. That is a systems problem, not a report.
No. Human-driven testing is still essential. It has to be repositioned as a targeted validation activity inside a broader, test-case-driven framework that ties findings to architecture and security controls. The pentest becomes one input rather than the whole story.
Senior testers are expensive. Expanding manual testing to the level of completeness a medical device needs, on every release, forever, is not economically viable, and postmarket makes it worse because testing is expected to recur. The math does not work with people alone.
The programs that hold up treat the security testing function as software that lives where the device is built and produces verdicts with evidence. The question under review is not whether you tested. It is whether you can show what you covered, what you did not, and why.