Credentials
A compact, audit‑friendly profile. Full CV is shared on request under private detail sharing if needed.
Domains
- EU MDR / IVDR (as applicable)
- QMS / ISO 13485
- ISO 14971 risk management
- Post‑Market Surveillance (PMS) and reporting (as applicable)
- UDI operations and submission readiness
Evidence links
Education
- DBA — Business Administration (2025)
- MBA — Business Administration (2022)
- PhD — Plasma Physics (2006)
Public profile
Non‑private context only.
- PRRC / QMB (QMR)
- EU MDR / IVDR
- FDA QSR (21 CFR Part 820)
- ISO 13485 • ISO 14971
- PMS / PMCF / PSUR / Vigilance
- ISO 13485 Lead Auditor — TÜV Rheinland
- Certified Quality Management Representative (QMR) — TÜV Rheinland
- Certified Risk Manager — TÜV NORD Academy
- Certified Project Manager — TÜV NORD Academy
- J&J / DePuy Synthes
- Danaher / Nobel Biocare
- HOYA / PENTAX Medical
- DSM / Pentapharm
Examples shown for context only; no endorsement implied.
We do not claim statutory roles (e.g., Authorized Representative/CH‑REP) unless explicitly stated on the relevant service page.
We do not publish sensitive work products. When deeper material is required, we share the minimum necessary in a private engagement (limited scope + selective sharing) with an auditable handover trail.
When we mention "audit‑grade", we mean traceable inputs, controlled outputs, and evidence that maps clearly to recognized standards and official guidance (as applicable). See Standards & References.
FWL.ai is not an ISO 13485‑certified organization. Deliverables are aligned to ISO 13485 / ISO 14971 practices where applicable.
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