Process Package — Vigilance Reporting Brazil (Notivisa) Complete framework for Brazilian medical device vigilance. Covers RDC 67/2009 reportability assessment, Notivisa submission, causality classification, foreign event tracking, and field actions. What’s included: SOP-VIG-BR Vigilance Reporting Brazil — full procedure with the 4-question reportability framework per RDC 67/2009, Notivisa submission process, causality classification, timelines (10 days for…
Process Package — Marketing Authorization Brazil (ANVISA) Complete framework for ANVISA medical device authorization. Covers BRH designation, classification under RDC 751/2022, Notificação vs Registro pathway selection, B-GMP certification (with MDSAP leverage), INMETRO and ANATEL conformity, and UDI/SIUD compliance (in force since July 2025). What’s included: SOP-REG-BR Marketing Authorization Brazil — full procedure: BRH designation criteria…
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.
Audit-ready Document Control SOP plus 3 templates: Master List, Change Request Form, and Record Destruction Authorization. Aligned with ISO 13485:2016 §4.2 and 21 CFR Part 11.
Process Package — Document and Record Control A complete, audit-ready document control system covering all requirements of ISO 13485:2016 §4.2.4–4.2.5, MDSAP Chapter 1, and 21 CFR Part 11 for electronic records. What’s included: SOP-CORE-01 Document and Record Control — full standard operating procedure with cover page, control page, responsibilities matrix, document hierarchy, lifecycle workflow, periodic…
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…
Process Package — Vigilance Reporting Canada Canada has TWO distinct reporting paths and both are audited. (1) MPR — Mandatory Problem Report under SOR/98-282 §59 with 10-day or 30-day timelines for events in Canada; (2) FRN — Foreign Risk Notification under §61.2 requiring 72-hour notification when a foreign regulator/manufacturer has taken corrective action abroad on…
Process Package — Internal Audit A complete internal audit system covering ISO 13485:2016 §8.2.4 and MDSAP Chapter 1 audit-readiness expectations. Risk-based programme planning, structured audits, and findings management with linkage to CAPA. What’s included: SOP-CORE-03 Internal Audit — full procedure including risk-based programme rationale, audit team competence, planning, conduct, reporting, NC grading methodology (5-tier per…
Process Package — Management Review Complete, audit-ready management review system covering ISO 13485:2016 §5.6 and MDSAP Chapter 1 expectations. Includes the 17 mandatory review inputs, output decisions framework, and integration with CAPA and KPI processes. What’s included: SOP-CORE-02 Management Review — full procedure with frequency, agenda structure, input checklist (all 17 ISO §5.6 inputs), output…
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…
Audit-ready MDSAP Program Management SOP. The master document tying together all MDSAP processes across 5 jurisdictions (Brazil, Japan, Canada, Australia, USA).
Process Package — Marketing Authorization Japan (PMDA) Complete framework for Japanese PMDA medical device authorization. Covers DMAH designation, Foreign Manufacturer Registration (Form 63-5), JMDN code mapping, the three pathways (Todokede / Ninsho / Shonin), STED dossier, ICH E5 ethnic factor assessment, and tempu bunsho management. What’s included: SOP-REG-JP Marketing Authorization Japan — full procedure: MAH/DMAH…
Process Package — Vigilance Reporting Japan (PMDA) Complete framework for Japanese medical device vigilance under PMD Act Art. 68-10. Covers the LISTED vs UNLISTED logic (events already in tempu bunsho follow 30-day path; UNLISTED follow stricter 15-day path), causality assessment, mandatory PSB/PSD fax notification for deaths, and tempu bunsho management strategy. What’s included: SOP-VIG-JP Vigilance…
