Risk-based IT validation that withstands audits — without overvalidating.
Independent consulting for regulated MedTech, pharmaceutical, and biotech organizations across Europe — bringing 15+ years of Nordic engineering practice in CSV, IT compliance, and digital transformation to engagements in Hungary, Central Europe, and remotely across the EU. Practical frameworks aligned with GAMP 5 principles, ICH Q9 risk thinking, and sound technical judgement applied to systems rather than to paperwork.
The approach
Help organizations define and apply validation boundaries, ownership, and decision logic across IT, QA, and business — applying GAMP 5 principles with sound judgement rather than excessive documentation.
My background combines Design Verification and system-level engineering with IT validation in GxP-regulated environments — a perspective increasingly relevant as life-science organizations move from paper-based, on-premise systems toward cloud platforms, integrated workflows, and digitalized QA. The same systematic, risk-based thinking that drives sound product verification also shapes how computerized systems should be classified, validated, and operated.
Today my work focuses on IT validation frameworks, CSV lifecycle activities, and digital transformation under regulatory constraints — typically engaged where organizations need to clarify what must be validated, what does not add value, and who owns the risk-based decisions: acting as a bridge between IT, QA, and business stakeholders to align regulatory expectations with operational reality.
Areas of focus
- IT Validation & CSV — FDA 21 CFR Part 11, EU GMP Annex 11
- Digital transformation in GxP — cloud platforms, integrated workflows, paperless QA
- Risk-based validation — GAMP 5, ICH Q9 principles
- System classification & SIA for computerized systems
- Design Verification & Validation — ISO 13485 lifecycle
- Test method validation — TMV, IQ/OQ/PQ, Gage R&R
- Regulatory submission support — FDA 510(k), CE-marking
- Aligning IT, QA, and business — translating compliance into operational decisions
Experience
Over 15 years across MedTech, pharmaceutical, and biotechnology environments in Sweden and Denmark — from early test planning and design verification to GxP-regulated IT validation in cloud-based and on-premise systems. Today delivering remote engagements across Hungary, Central Europe, and the EU.
IT Validation Manager
European biopharmaceutical company · long-acting drug delivery technologies
Responsible for establishing and maintaining risk-based IT validation frameworks across computerized systems in a GxP-regulated QA context. Supporting the full CSV lifecycle — classification, risk assessment, SIA, planning, execution oversight, and documentation — under GAMP 5, EU GMP Annex 11, and FDA 21 CFR Part 11, across cloud and infrastructure systems. Interface between IT, QA, and business, translating regulatory expectations into pragmatic, technically sound approaches.
Principal Test & Automation Engineer
Global manufacturer of audiology and neurodiagnostic devices
Led test automation for audiology devices — design and maintenance of LabVIEW-based systems for PCBA and final assembly testing. Collaborated externally on test solutions for upcoming hardware platforms. Drove automation process improvements and supported daily issue handling and documentation.
R&D Specialist · Verification & Validation
Global leader in blood gas analyzers and acute-care diagnostics
Led verification on hardware updates for a blood gas analyzer platform — test plans and execution for electrical safety and mechanical features. Built automated lifetime and test method validation (TMV) rigs for new hardware. Analyzed test data with JMP, supporting Gage R&R and validation planning with production testing teams.
Test & Verification Engineer
Danish manufacturer of single-use medical devices · endoscopy and patient monitoring
Delivered Design Verification input to traceability matrices. Defined verification requirements and test plans for single-use endoscope systems and monitors. Supported sterile-device mechanical testing (torque, pull, dielectric) and contributed to regulatory submissions. Introduced updated sample size guidance, strengthening risk-based test strategies in a fast-growing R&D environment.
Principal Engineer · System Verification
Multinational medical device and pharmaceutical company · renal care
Drove Design Verification from hardware modules to small software projects — test strategy, planning, and execution. Led system-level verification for multiple dialysis system generations, securing compliance for FDA 510(k) and CE-marking submissions. Developed verification for critical components (pressure/flow sensors, valves, conductivity sensors). Conducted automated hardware testing with LabVIEW and EMC/environmental testing both in-house and externally.
- Education
- BSc · Computer & Electrical Engineering, Lund University
- Standards
- GAMP 5 · ICH Q9 · ISO 13485 · ISO 14971 · EU GMP Annex 11 · FDA 21 CFR Part 11
- Languages
- Swedish (native) · English (full professional) · Danish (B2 certified)
- Engagements
- Based in Sweden · Engagements across Hungary, Central Europe, and the EU · remote-first
Get in touch
Independent engagements considered — typically validation framework reviews, CSV lifecycle activities, audit readiness, or risk-based test strategy work.
For discussions about a specific engagement or a longer conversation about how your organization approaches IT validation, reach out via the channel below.
hello@medval.hu