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Process Package — Corrective and Preventive Action (CAPA) A complete CAPA system covering ISO 13485:2016 §8.5.2–8.5.3, MDSAP Chapter 1–2, and FDA QMSR expectations. CAPA is the most-cited finding area in regulatory audits — this package addresses it head-on with a lifecycle-complete template and a procedure that integrates risk-based prioritization. What’s included: SOP-CORE-04 CAPA — full…
Complete ISO 13485 QMS Documentation Kit — All 30 Process Packages + Quality Manual + Master Tracker. Aligned with ISO 13485:2016, EU MDR 2017/745, FDA QMSR, and MDSAP.
Design and Development Control SOP with 6 templates: Plan, I/O Matrix (Excel), Review Record, Verification, Validation, Transfer Checklist. Largest package in the kit.
Process 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…
Process 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…
MDSAP Documentation Kit — Complete The flagship kit. Everything your QMS needs to face an MDSAP audit confidently across all 5 jurisdictions: Brazil, Japan, Canada, Australia, USA. 15 procedures + 18 templates + a User Guide and Master Index, all aligned to the latest 2025-2026 regulatory frameworks. What’s included: Shared Core (4 procedures + 8…
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