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.
ISO 13485 · QMS Documentation
ISO 13485 Documentation
A complete, customizable QMS documentation kit aligned with ISO 13485:2016/A11:2021, EU MDR, FDA QMSR (effective Feb 2026), and MDSAP.
- Audit-ready
- EU MDR + FDA QMSR + MDSAP aligned
- Word & Excel, fully editable
- Quality Manual + Master Tracker
MD REGULATORY
ISO 13485
QMS Documentation
Kit - v1.0
- 30 SOPs + 56 Templates
- Quality Manual + Master Tracker
- EU MDR + FDA QMSR aligned
- Audit-ready
ISO 13485:2016/A11:2021
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Complete ISO 13485 QMS Documentation Kit
Everything in one bundle. Quality Manual, all 30 process packages, Master Tracker, README, and Master Index. The fastest path from blank slate to audit-ready QMS.
Quality Manual (top-level QMS document)
30 SOPs (4 Shared Core + 26 ISO-specific)
56 templates (forms, plans, reports, registers)
Master Tracker (7 operational logs in one)
23 pre-populated KPIs
Aligned with EU MDR + FDA QMSR + MDSAP
README with quick start guide
Master Index (Excel) for navigation
€499
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vs €2,070 buying separately (30 × €69)
Or buy individual packages — €69 each
Each package = SOP + linked templates. 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.
Corrective and Preventive Action
SOP + comprehensive CAPA template covering full lifecycle: Initiation, Triage, Risk Prioritization (P1/P2/P3), RCA, Action Plan, Effectiveness, Closure.
Human Resources and Training
SOP + Job Description (PRRC role per Art. 15), Training Plan & Record (Excel), Competence Matrix (16 pre-populated competences).
KPI and 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).
Advisory Notice and FSCA
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. Largest package.
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 and Control
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. SOP only — supplier-provided validation.
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.
Strategy for Regulatory Compliance
SOP + PRRC Qualification Record per EU MDR Art. 15(1) — pathway (a) or (b). Aligned with MDCG 2019-7.
Labelling and Translation Management
SOP + combined Label/IFU/Translation Validation template. Aligned with EU MDR Annex I §23 + ISO 15223-1 + ISO 20417.
Notified Body Change Notification
SOP + comprehensive NB Change Notification Form per EU MDR Art. 56(2) + MDCG 2020-3.
Infrastructure and Equipment Control
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 — 6 sample suppliers) + bilateral Quality Agreement.
Purchase Management
SOP + combined Purchase Specification (Part A) + PO (Part B) template.