GILB ROMAN INTREPRINDERE INDIVIDUALA

I support MedTech companies with 𝗧𝗲𝗰𝗵𝗻𝗶𝗰𝗮𝗹 𝗗𝗼𝗰𝘂𝗺𝗲𝗻𝘁𝗮𝘁𝗶𝗼𝗻 (𝗠𝗗𝗥/𝗜𝗩𝗗𝗥) that is 𝗹𝗲𝗮𝗻, 𝘁𝗿𝗮𝗰𝗲𝗮𝗯𝗹𝗲 and 𝗮𝘂𝗱𝗶𝘁-𝗿𝗲𝗮𝗱𝘆. Focus: Requirements → Tests/Reviews → robust Evidence.

Also transferable to safety-critical products outside MedTech: the requirements-to-test-evidence setup (automotive, defence, rail, aerospace).

𝗞𝗲𝘆 𝗗𝗲𝗹𝗶𝘃𝗲𝗿𝗮𝗯𝗹𝗲𝘀:
𝗥𝗲𝗾𝘂𝗶𝗿𝗲𝗺𝗲𝗻𝘁𝘀 & 𝗧𝗿𝗮𝗰𝗲𝗮𝗯𝗶𝗹𝗶𝘁𝘆 (𝗥𝗧𝗠), 𝗩&𝗩 (𝗩𝗲𝗿𝗶𝗳𝗶𝗰𝗮𝘁𝗶𝗼𝗻 & 𝗩𝗮𝗹𝗶𝗱𝗮𝘁𝗶𝗼𝗻): Verification Plan / Test Strategy, Test Protocols (step-by-step), Test Reports (evidence), plus 𝗜𝗦𝗢 𝟭𝟰𝟵𝟳𝟭 (Risk Management) / 𝗜𝗘𝗖 𝟲𝟮𝟯𝟲𝟲-𝟭 (Usability/Human Factors) as an integrated interface into traceability.

🔹 𝗥𝗧𝗠 / 𝗧𝗿𝗮𝗰𝗲𝗮𝗯𝗶𝗹𝗶𝘁𝘆
Structure requirements to be clear, consistent and testable, and link them in the RTM (traceability matrix), from design inputs/standards/risk-usability inputs → requirements → tests.

🔹 𝗩𝗲𝗿𝗶𝗳𝗶𝗰𝗮𝘁𝗶𝗼𝗻 & 𝗧𝗲𝘀𝘁 𝗗𝗼𝗰𝘂𝗺𝗲𝗻𝘁𝗮𝘁𝗶𝗼𝗻 (𝗵𝗮𝗻𝗱𝘀-𝗼𝗻)
Create a Verification Plan/Test Strategy, Test Protocols (step-by-step) and Test Reports as robust evidence. Depending on the project, this can include hands-on execution (test setup, execution, analysis) and standards-compliant documentation, e.g. in the context of 𝗜𝗘𝗖 𝟲𝟬𝟲𝟬𝟭-𝟭 / 𝗜𝗘𝗖 𝟲𝟭𝟬𝟭𝟬.

🔹 𝗜𝗦𝗢 𝟭𝟰𝟵𝟳𝟭 / 𝗜𝗘𝗖 𝟲𝟮𝟯𝟲𝟲-𝟭 (𝗿𝗲𝗮𝗹𝗶𝘀𝘁𝗶𝗰)
Practical application at the interface: deriving/linking to requirements and tests, consistency checks and traceability; full risk and usability documentation depending on project scope and/or together with specialists.

📌 𝗠𝗗𝗥/𝗜𝗩𝗗𝗥 is the core regulatory framework, including 𝗤𝗠𝗦 interfaces (𝗜𝗦𝗢 𝟭𝟯𝟰𝟴𝟱). 𝗙𝗗𝗔 topics are covered as Documentation Support/Exposure, with focus on structure, traceability and evidence logic.

💡 Approach: 𝗹𝗲𝗮𝗻, 𝘁𝗿𝗮𝗰𝗲𝗮𝗯𝗹𝗲, 𝗮𝘂𝗱𝗶𝘁-𝗿𝗲𝗮𝗱𝘆 — no more documents than needed, but enough for robust evidence and market access.

🧰 SERVICES

- Technical Documentation (MDR/IVDR)
    
- Requirements Engineering (MedTech)
    
- Traceability Matrix (RTM) – Setup & Maintenance
    
- V&V & Test Documentation (IEC 60601-1 / IEC 61010-1) – Plans, Protocols & Reports
    
- Evidence Package – Traceability, Evidence Logic & Review Readiness
    
- Risk Management & Usability (ISO 14971 / IEC 62366-1) – Traceability & Interface Support- Technical Documentation (MDR/IVDR)
    
- Requirements Engineering (MedTech)
    
- Traceability Matrix (RTM) – Setup & Maintenance
    
- V&V & Test Documentation (IEC 60601-1 / IEC 61010-1) – Plans, Protocols & Reports
    
- Evidence Package – Traceability, Evidence Logic & Review Readiness
    
- Risk Management & Usability (ISO 14971 / IEC 62366-1) – Traceability & Interface Support