Document and Record Control
SOP + 3 templates: Master List (Excel), Change Request Form, Record Destruction Authorization. Aligned with ISO 13485, MDSAP and 21 CFR Part 11.
MDSAP Documentation Hub
MDSAP Documentation
The complete audit-readiness kit for the Medical Device Single Audit Program. Cover all 5 jurisdictions — Brazil, Japan, Canada, Australia and the USA — with one consistent set of SOPs and templates. Or buy only the process you need.
15 SOPs + 18 templates
5 jurisdictions covered
Word & Excel format
Instant download
MD Regulatory
MDSAP
Documentation Kit — Complete
15 SOPs + 18 editable templates
5 jurisdictions: BR · JP · CA · AU · USA
Word & Excel — fully editable
Instant download after purchase
Complete Bundle
MDSAP Documentation Kit
Everything you need to face an MDSAP audit confidently across all five participating jurisdictions. 15 procedures, 18 templates, plus Quick Start User Guide and a complete Master Index — all aligned to the latest 2025-2026 regulatory frameworks including FDA QMSR, ANVISA RDC 591/2021, AusUDID and PRAC.
15 SOPs included
18 editable templates
All 5 MDSAP countries
FDA QMSR (Feb 2026) aligned
Word & Excel format
User Guide + Master Index
€399
one-time payment · lifetime access
⚡ Save 61% vs buying packages individually (€1,035 → €399)
Or buy only the SOP you need
Each Process Package includes the SOP plus its templates, ready to integrate into your existing QMS.
Filter by jurisdiction or by process type:
Jurisdiction
Process Type
Management Review
SOP + combined Agenda + Minutes template. Covers all 17 mandatory ISO 13485 §5.6 inputs and MDSAP-specific outputs.
Internal Audit
SOP + 3 templates: Annual Programme (Excel), Audit Plan, Audit Report. Risk-based with MDSAP coverage tracking and NC grading.
CAPA
SOP + 11-page combined template covering all stages: Initiation, Triage, Risk Prioritization (P1/P2/P3), RCA (5-Whys + Ishikawa), Action Plan, Effectiveness, Closure.
MDSAP Program Management
The master MDSAP program SOP. Ties together all MDSAP processes across the 5 jurisdictions with audit cycle, AO management, and chapter-task matrix.
Brazil Marketing Authorization
ANVISA registration SOP + Classification + Pathway Decision template. Covers RDC 751/2022 (22 rules), B-GMP, INMETRO/ANATEL, UDI/SIUD, BRH framework.
Japan Marketing Authorization
PMDA registration SOP + JMDN Classification + Pathway template. Covers Shonin/Ninsho/Todokede pathways, KYOKA Type, Form 63-5, ICH E5 ethnic factors.
Canada Marketing Authorization
Health Canada MDL/MDEL SOP + Classification + MDL Application Checklist. Schedule 1 (16 rules), MDSAP-as-evidence, ALR, bilingual labeling, senior officer attestation.
Australia Marketing Authorization
TGA ARTG inclusion SOP + Conformity Assessment Pathway Selection template. 5 pathways (TGA-CA, CE Mark, MDSAP, COR, Self-decl), Sponsor framework, AusUDID.
USA Marketing Authorization
FDA pathway SOP + Pathway Selection + Substantial Equivalence Matrix (Excel, 4 sheets). 510(k), De Novo, PMA. SE matrix and submission readiness checklist included.
Brazil Vigilance Reporting
ANVISA Notivisa SOP + Brazilian Reportability Decision Worksheet. Covers RDC 67/2009 4-question framework, causality assessment, 10/30-day timelines.
Japan Vigilance Reporting
PMDA vigilance SOP + Japanese Reportability Decision Worksheet. Covers PMD Act Art. 68-10, the unique LISTED vs UNLISTED tempu bunsho logic, 15/30-day timelines.
Canada Vigilance Reporting
Health Canada MPR + FRN SOP + combined worksheet. Covers SOR/98-282 §59 (10/30-day MPR) AND §61.2 (Foreign Risk Notification 72-hour deadline).
Australia Vigilance Reporting
TGA MDIR SOP + Exemption Justification Worksheet. Covers TG (MD) Regulations 2002, the Australia-specific exemption mechanism, PRAC integration.
USA Vigilance Reporting
FDA MDR SOP + FDA MDR Reportability Decision Worksheet. Covers 21 CFR Part 803, the 'malfunction recurrence' criterion, 30-day vs 5-day timelines, eMDR submission.
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