Document and Record Control
SOP + 3 templates: Master List (Excel), Change Request Form, Record Destruction Authorization. Aligned with ISO 13485 §4.2 and 21 CFR Part 11.
Premium Bundle · ISO 13485 + MDSAP
The Ultimate Global QMS Documentation Bundle
Combine our ISO 13485 QMS Kit with our MDSAP Documentation Kit in one premium package. ISO 13485:2016/A11:2021, EU MDR, FDA QMSR, and all 5 MDSAP markets (Brazil, Japan, Canada, Australia, USA) — one integrated foundation, no duplication.
41
SOPs
70+
Templates
122
Files Total
SAVE €199
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Combined Kit ISO 13485 + MDSAP
Everything from our ISO 13485 Kit plus everything from our MDSAP Kit, in one deduplicated structure. Operate globally with a single integrated QMS foundation, not two parallel systems.
Quality Manual + Master Tracker
41 SOPs (4 Core + 26 ISO + 11 MDSAP)
70+ templates ready to customize
5 MDSAP markets (BR/JP/CA/AU/US)
19-step Implementation Roadmap
Aligned with EU MDR + FDA QMSR + MDSAP
23 pre-populated KPIs
README + Master Index (5 sheets)
€699
vs €898 buying separately (ISO €499 + MDSAP €399)
Or buy individual packages — €69 each
All 41 process packages included in the Combined Kit are also available individually. Filter by area to focus on what you need now.
Management Review
SOP + combined Agenda + Minutes template. All 17 mandatory ISO 13485 §5.6 inputs covered.
Internal Audit
SOP + 3 templates: Annual Programme (Excel), Audit Plan, Audit Report. Risk-based per ISO 19011.
CAPA
SOP + comprehensive CAPA template covering full lifecycle: Initiation, Triage, Risk Prioritization (P1/P2/P3), RCA, Action Plan, Effectiveness, Closure.
HR & Training
SOP + Job Description (PRRC role per Art. 15), Training Plan & Record (Excel), Competence Matrix (16 pre-populated competences).
KPI & Data Analysis
SOP + KPI Catalog & Dashboard (Excel — 23 pre-populated KPIs, 90 auto-calc formulas) + Quality Objectives Tracker.
Computer System Validation
SOP + Validation Plan & Report + IQ/OQ/PQ Protocol templates. Aligned with GAMP 5 + 21 CFR Part 11.
Nonconformance Management
SOP + comprehensive NC Report template (severity classification, RCA, disposition, CAPA linkage).
Risk Management
SOP + 4 templates: RM Plan, RM Report, Risk Analysis Matrix (Excel auto-RPN), URRA per IEC 62366-1. Aligned with ISO 14971:2019/A11:2021.
Clinical Evaluation
SOP + CEP + CER templates. Aligned with EU MDR Annex XIV + MDCG 2020-5 (equivalence) + MDCG 2020-13 (CEAR).
EU Vigilance Reporting
SOP + PSUR template per MDCG 2022-21. Covers Art. 87-92 timelines and EUDAMED submission.
Complaint Management
SOP + Complaint File template with INTEGRATED 4-question Reportability Assessment per Art. 87.
Customer Related Processes
SOP + Customer Order / Contract Review Form (per ISO 13485 §7.2.2).
FSCA & Field Safety Notice
SOP + FSCA Decision Worksheet + Field Safety Notice (FSN) per MDCG 2024-1. 5-tier categorization.
Post-Market Surveillance
SOP + PMS Plan + PMS Report (Class I) templates. Aligned with EU MDR Art. 84-86 + MDCG 2022-21.
Change Control
SOP + Change Control Form with MDCG 2020-3 substantial change assessment matrix integrated.
Design and Development Control
SOP + 6 templates: Plan, I/O Matrix (Excel), Review, Verification, Validation, Transfer Checklist.
Process Validation
SOP + VMP + IQ/OQ Protocol + PQ Report templates. Aligned with FDA Process Validation Guidance 2011 (Stage 1-2-3).
Production and Service Provision
SOP + Manufacturing Process Specification (equivalent to FDA Device Master Record per 21 CFR 820.181).
Incoming Inspection
SOP + Inspection Plan & Report (Excel) + CoA/CoC Review Record. AQL sampling per ANSI/ASQ Z1.4.
Sterilization Process Validation
SOP for outsourced sterilization framework per ISO 11135/17665/11137.
Usability Engineering
SOP + Use Spec & URRA combined + UEF Summary. Aligned with IEC 62366-1 + FDA HFE 2016.
UDI Management
SOP + UDI Master List (Excel) for EUDAMED + FDA GUDID submission tracking. Multi-issuing-entity ready.
Medical Device File
SOP + MDF Index aligned with EU MDR Annex II §1-6 + Annex III. Equivalent to FDA DMR.
Regulatory Strategy
SOP + PRRC Qualification Record per EU MDR Art. 15(1) — pathway (a) or (b). Aligned with MDCG 2019-7.
Labelling and Translation
SOP + combined Label/IFU/Translation Validation template. Aligned with EU MDR Annex I §23 + ISO 15223-1 + ISO 20417.
NB Change Notification
SOP + comprehensive NB Change Notification Form per EU MDR Art. 56(2) + MDCG 2020-3.
Infrastructure
SOP + Equipment Master List (Excel — auto-calc Days Until Cal) + Maintenance & Calibration Record.
Supplier Management
SOP + 3 templates: Supplier Evaluation Form + Approved Supplier List (Excel) + bilateral Quality Agreement.
Purchase Management
SOP + combined Purchase Specification (Part A) + PO (Part B) template.
MDSAP Program Management
Master MDSAP program SOP. Ties together all 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.
Australia Marketing Authorization
TGA ARTG inclusion SOP + Conformity Assessment Pathway Selection. 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, 'malfunction recurrence' criterion, 30-day vs 5-day timelines, eMDR submission.