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MedTech / FDA 524B · database

TÜV SÜD

Partially verified

Global testing, inspection, and certification company with a dedicated medical device cybersecurity practice: penetration tests and fuzz testing, concept evaluations, vulnerability scans and code analysis, and regulatory compliance testing across FDA, EU MDR, and IVDR.

Credential verification

Public-tier claims with issuer citations; registry verification pending.

Certifications are held by individuals, never organizations. Org-level status below is a DERIVED rollup of named holders, the org claims nothing its holders do not hold. Issuer directories (GIAC, (ISC)², ISACA) list individual certificate holders with expiration dates, registry lookups resolve at the named-holder level and require no carrier data.

No certifications documented for this firm.

Something wrong or outdated on this listing? Request a correction with the public sources that show it.

Panels & coverage

Insurance panels

None documented

Regions
Global

Profile

Tagline: Medical device cybersecurity, certification & testing
HQ: Munich, Germany
Service area: Global
Size: Global TIC organization, size not documented on the medical pages

TÜV SÜD's medical device cybersecurity page documents a comprehensive service range it describes as spanning training, concept evaluation, and testing and assessing regulatory compliance, with named services including penetration tests and fuzz testing, concept evaluations, vulnerability scans and static/dynamic code analysis, and cybersecurity trainings. The page frames the practice against FDA guidance and the EU MDR and IVDR requirements.

Sourced from the firm's published pages (October 2026). The platform's full verification pass, including registry checks of any certifications, is pending.

Services & engagements

Services
Penetration tests and fuzz testing for medical devicesConcept evaluationsVulnerability scans and static/dynamic code analysisRegulatory compliance testing and assessment (FDA, EU MDR, IVDR)Cybersecurity trainings

Documented engagements

None found

No publicly documented case work was found on the firm's own site at the time of our research. Some firms publish engagement details under NDA restrictions; some simply do not publish. The absence of documented work is a fact, not a judgment.

Certification & testingMedTech