Cybersecurity Risk Assessment & Threat Model
€69.00Security risk assessment and threat model using STRIDE + DREAD + CIA, aligned to IEC 81001-5-1 and the FDA 2023 cybersecurity guidance.
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FDA 510(k) SOP + Substantial Equivalence Matrix — 21 CFR & QMSR (USA)
€69.00Process Package — Marketing Authorization USA (FDA) Complete framework for FDA medical device authorization. Covers 21 CFR 862-892 classification, the four pathways (Exempt / 510(k) / De Novo / PMA), Establishment Registration and Listing, UDI/GUDID, eSTAR submissions (mandatory for 510(k) since Oct 2023), and the FDA QMSR transition (in force Feb 2026). What’s included: SOP-REG-US…
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FDA MDR SOP + Reportability Worksheet — 21 CFR Part 803 (USA)
€69.00Process Package — Vigilance Reporting USA (FDA MDR) Complete framework for FDA Medical Device Reporting under 21 CFR Part 803. Covers MDR reportability (death/serious injury caused or contributed to, plus the unique ‘malfunction recurrence’ criterion), 30-day standard timeline vs 5-day expedited reporting, eMDR submission via the FDA Electronic Submissions Gateway, and the §803.18 records retention…
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Predetermined Change Control Plan — PCCP (AI-05)
€69.00The flagship PCCP — pre-authorised modifications, modification protocol and impact assessment, aligned to FDA and Health Canada nomenclature.
