Services / Medical device & SaMD
Medical-device & SaMD web application test
For software as a medical device and connected-device portals: a full application and API test, documented so the results drop straight into your cybersecurity file.
What's included
- Everything in the web application & API test
- Test plan and test specification written before testing, so the work is traceable
- Findings mapped to your security risk management (ISO 14971-aligned) and threat model
- Evidence structured for FDA premarket cybersecurity documentation and EU MDR Annex I security requirements
- Commentary on residual risk in language a reviewer or auditor expects
- One retest of fixed findings, included
Scope
- The web application, its APIs and its administrative interfaces
- Device-adjacent interfaces in scope where they are reachable over the web
- Mapping of findings to your security risk management file
Who it's for
- SaMD and connected-device manufacturers preparing an FDA submission
- Manufacturers answering notified-body or auditor questions on security testing
- Device companies whose hospital customers require independent testing
What you get
- Test plan and test specification (pre-test)
- Technical report with traceable test cases and evidence
- Summary suitable for inclusion in a submission or technical file
- Retest letter confirming what has been fixed
Report delivered within 5 working days of testing ending. One retest of fixed findings included, within 60 days.
report/ technical-report.pdf findings, evidence, fixes management-summary.pdf for the board or a customer findings.csv straight into your tracker retest/ retest-letter.pdf after you've fixed things
How the engagement runs
Scope
A short call about the application, its roles and what would hurt most if it broke. You get a fixed-price proposal and dates.
Authorise
Rules of engagement, authorisation and an NDA if you want one. Testing starts only once these are signed.
Map
Reconnaissance and mapping: every route, role, parameter and API call that makes up the attack surface.
Test
Manual testing against the OWASP guides, supported by tooling. Critical findings are reported the moment they are confirmed, not held for the report.
Report
Findings with evidence, reproduction steps, CVSS ratings and fix guidance written for developers, plus a summary for everyone else.
Retest
Once you have fixed things, a retest confirms it, and you get a letter you can show customers or auditors.
Questions
Does this guarantee our submission will be accepted?
No, and be wary of anyone who says it will. What it gives you is independent test evidence, structured and traceable, that supports the security documentation a submission or technical file needs.
Can you work alongside our regulatory consultant?
Yes. The report is written so a regulatory reviewer can use it directly. MD QMS Ltd. also does regulatory and cybersecurity documentation work if you need the wider file built.
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Get a fixed price for your application
A 20-minute scoping call, then a fixed-price proposal. No obligation, and no pressure to buy a bigger scope than you need.
Fixed-price quote within 2 working days of the scoping call · Report delivered within 5 working days of testing ending · One retest of fixed findings included, within 60 days