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MedTech / FDA 524B · database

MDI Consultants

Partially verified

FDA regulatory consultancy with 45 years and 1,800+ submissions, documented from public research.

Visit mdiconsultants.com

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.

Panels & coverage

Insurance panels

None documented

Regions

Not documented

Profile

Tagline: Documented from public research
Service area:
Size: not documented

Documented from public research (firm website and cited public pages, read September 2026).

Documents 45 years of FDA regulatory experience with 1,800+ submissions. (cited sources on file, September 2026).

Publishes software penetration testing for FDA 524B and ISO 27001 compliance. (cited sources on file, September 2026).

Sourced from public research; the platform's full verification pass is pending.

Services & engagements

Services
510(k)/PMA submissionsSoftware penetration testingWarning letter response

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 Some firms publish engagement details under NDA restrictions; some simply do not publish.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.

FDA 510(k)524BPenetration Testing