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.
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…
Process Package — Marketing Authorization Australia (TGA) Complete framework for Australian TGA ARTG inclusion. Covers Sponsor designation, classification under TG (MD) Regulations 2002, the five conformity assessment pathways, Essential Principles (Schedule 2), AusUDID (effective 2025), and Annual Reports for ARTG-included devices. What’s included: SOP-REG-AU Marketing Authorization Australia — full procedure: Sponsor designation, classification rules, 5…
