Browse All Compliance Kits
Complete bundles or individual process packages — choose what fits your audit needs. All documents instantly downloadable, fully editable in Word & Excel.
Complete Kits
Audit-ready bundles covering all processes for a specific standard or framework.
✦ Most Popular
ISO 13485 QMS Kit
Complete QMS documentation aligned with ISO 13485, EU MDR, FDA QMSR and MDSAP. 30 SOPs, 56 templates, Quality Manual + Master Tracker.
✓ 88 files · ✓ Word & Excel
✦ Multi-Market
MDSAP Documentation Kit
Single-audit documentation for 5 markets — Brazil, Japan, Canada, Australia and USA. 15 SOPs and 18 templates aligned with the MDSAP audit model.
✓ 35 files · ✓ 5 jurisdictions
✦ New · EU MDR
Clinical Documentation Kit
Audit-ready clinical and post-market documentation for EU MDR. 8 Word templates: CEP, CER, CDP, PMS, PSUR, PMCF Plan, PMCF Report, SSCP.
✓ 8 templates · ✓ MDCG-aligned
✦ Premium Bundle
Combined Kit ISO + MDSAP
The ultimate global QMS bundle — every ISO 13485 process plus all 5 MDSAP markets in one premium package for global medical device manufacturers.
✓ 122 files · ✓ Save €199
Individual Process Packages
53 packages available — each is one SOP plus its linked templates. €69 each.
| Standard | Type | Process | Description | Price | |
|---|---|---|---|---|---|
| ISO 13485 | 🔧 Core | Document and Record ControlMaster List (Excel) + Change Request Form + Record Destruction Authorization | Master List (Excel) + Change Request Form + Record Destruction Authorization | €69 | View → |
| ISO 13485 | 🔧 Core | Management ReviewCombined Agenda + Minutes template covering all 17 ISO 13485 §5.6 inputs | Combined Agenda + Minutes template covering all 17 ISO 13485 §5.6 inputs | €69 | View → |
| ISO 13485 | 🔧 Core | Internal AuditAnnual Programme (Excel) + Audit Plan + Audit Report. Risk-based per ISO 19011 | Annual Programme (Excel) + Audit Plan + Audit Report. Risk-based per ISO 19011 | €69 | View → |
| ISO 13485 | 🔧 Core | CAPAComprehensive CAPA template covering full lifecycle: Initiation, RCA, Effectiveness | Comprehensive CAPA template covering full lifecycle: Initiation, RCA, Effectiveness | €69 | View → |
| ISO 13485 | 📋 QMS | HR & TrainingJob Description (PRRC role) + Training Plan & Record + Competence Matrix | Job Description (PRRC role) + Training Plan & Record + Competence Matrix | €69 | View → |
| ISO 13485 | 📋 QMS | KPI & Data Analysis23 pre-populated KPIs with 90 auto-calc formulas + Quality Objectives Tracker | 23 pre-populated KPIs with 90 auto-calc formulas + Quality Objectives Tracker | €69 | View → |
| ISO 13485 | 📋 QMS | Computer System ValidationValidation Plan + IQ/OQ/PQ Protocol templates aligned with GAMP 5 + 21 CFR Part 11 | Validation Plan + IQ/OQ/PQ Protocol templates aligned with GAMP 5 + 21 CFR Part 11 | €69 | View → |
| ISO 13485 | 📋 QMS | Nonconformance ManagementNC Report template (severity classification, RCA, disposition, CAPA linkage) | NC Report template (severity classification, RCA, disposition, CAPA linkage) | €69 | View → |
| ISO 13485 | ⚠️ Risk Mgmt | Risk ManagementRM Plan + RM Report + Risk Analysis Matrix (auto-RPN) + URRA per ISO 14971 | RM Plan + RM Report + Risk Analysis Matrix (auto-RPN) + URRA per ISO 14971 | €69 | View → |
| ISO 13485 | 🫓 Clinical & PMS | Clinical EvaluationCEP + CER templates aligned with EU MDR Annex XIV + MDCG 2020-5/13 | CEP + CER templates aligned with EU MDR Annex XIV + MDCG 2020-5/13 | €69 | View → |
| ISO 13485 | 🫓 Clinical & PMS | EU VigilancePSUR template per MDCG 2022-21. Covers EU MDR Art. 87-92 + EUDAMED | PSUR template per MDCG 2022-21. Covers EU MDR Art. 87-92 + EUDAMED | €69 | View → |
| ISO 13485 | 🫓 Clinical & PMS | Complaint ManagementComplaint File template with integrated 4-question Reportability Assessment | Complaint File template with integrated 4-question Reportability Assessment | €69 | View → |
| ISO 13485 | 🫓 Clinical & PMS | Customer Related ProcessesCustomer Order / Contract Review Form per ISO 13485 §7.2.2 | Customer Order / Contract Review Form per ISO 13485 §7.2.2 | €69 | View → |
| ISO 13485 | 🫓 Clinical & PMS | FSCA & Field Safety NoticeFSCA Decision Worksheet + FSN per MDCG 2024-1. 5-tier categorization | FSCA Decision Worksheet + FSN per MDCG 2024-1. 5-tier categorization | €69 | View → |
| ISO 13485 | 🫓 Clinical & PMS | Post-Market SurveillancePMS Plan + PMS Report (Class I) per EU MDR Art. 84-86 + MDCG 2022-21 | PMS Plan + PMS Report (Class I) per EU MDR Art. 84-86 + MDCG 2022-21 | €69 | View → |
| ISO 13485 | 🎨 Design & Production | Change ControlChange Control Form with MDCG 2020-3 substantial change assessment matrix | Change Control Form with MDCG 2020-3 substantial change assessment matrix | €69 | View → |
| ISO 13485 | 🎨 Design & Production | Design ControlDesign Plan + I/O Matrix + Review/Verification/Validation + Transfer Checklist | Design Plan + I/O Matrix + Review/Verification/Validation + Transfer Checklist | €69 | View → |
| ISO 13485 | 🎨 Design & Production | Process ValidationVMP + IQ/OQ Protocol + PQ Report per FDA Process Validation Guidance 2011 | VMP + IQ/OQ Protocol + PQ Report per FDA Process Validation Guidance 2011 | €69 | View → |
| ISO 13485 | 🎨 Design & Production | ProductionManufacturing Process Specification (equivalent to FDA DMR per 21 CFR 820.181) | Manufacturing Process Specification (equivalent to FDA DMR per 21 CFR 820.181) | €69 | View → |
| ISO 13485 | 🎨 Design & Production | Incoming InspectionInspection Plan & Report (Excel) + CoA/CoC Review. AQL per ANSI/ASQ Z1.4 | Inspection Plan & Report (Excel) + CoA/CoC Review. AQL per ANSI/ASQ Z1.4 | €69 | View → |
| ISO 13485 | 🎨 Design & Production | SterilizationSOP for outsourced sterilization framework per ISO 11135/17665/11137 | SOP for outsourced sterilization framework per ISO 11135/17665/11137 | €69 | View → |
| ISO 13485 | 🎨 Design & Production | Usability EngineeringUse Spec & URRA combined + UEF Summary per IEC 62366-1 + FDA HFE 2016 | Use Spec & URRA combined + UEF Summary per IEC 62366-1 + FDA HFE 2016 | €69 | View → |
| ISO 13485 | 📁 Regulatory | UDI ManagementUDI Master List for EUDAMED + FDA GUDID submission tracking | UDI Master List for EUDAMED + FDA GUDID submission tracking | €69 | View → |
| ISO 13485 | 📁 Regulatory | Medical Device FileMDF Index aligned with EU MDR Annex II §1-6 + Annex III. Equivalent to FDA DMR | MDF Index aligned with EU MDR Annex II §1-6 + Annex III. Equivalent to FDA DMR | €69 | View → |
| ISO 13485 | 📁 Regulatory | Regulatory StrategyPRRC Qualification Record per EU MDR Art. 15(1) + MDCG 2019-7 | PRRC Qualification Record per EU MDR Art. 15(1) + MDCG 2019-7 | €69 | View → |
| ISO 13485 | 📁 Regulatory | LabellingCombined Label/IFU/Translation Validation per EU MDR Annex I §23 + ISO 15223-1 | Combined Label/IFU/Translation Validation per EU MDR Annex I §23 + ISO 15223-1 | €69 | View → |
| ISO 13485 | 📁 Regulatory | NB Change NotificationNB Change Notification Form per EU MDR Art. 56(2) + MDCG 2020-3 | NB Change Notification Form per EU MDR Art. 56(2) + MDCG 2020-3 | €69 | View → |
| ISO 13485 | 🚚 Purchase & Infra | InfrastructureEquipment Master List (auto-calc Days Until Cal) + Maintenance & Calibration Record | Equipment Master List (auto-calc Days Until Cal) + Maintenance & Calibration Record | €69 | View → |
| ISO 13485 | 🚚 Purchase & Infra | Supplier ManagementSupplier Evaluation + Approved Supplier List + bilateral Quality Agreement | Supplier Evaluation + Approved Supplier List + bilateral Quality Agreement | €69 | View → |
| ISO 13485 | 🚚 Purchase & Infra | Purchase ManagementCombined Purchase Specification (Part A) + PO (Part B) template | Combined Purchase Specification (Part A) + PO (Part B) template | €69 | View → |
| MDSAP | 🔧 Core | Document and Record ControlSOP + 3 templates: Master List, Change Request Form, Record Destruction Authorization | SOP + 3 templates: Master List, Change Request Form, Record Destruction Authorization | €69 | View → |
| MDSAP | 🔧 Core | Management ReviewCombined Agenda + Minutes template covering all 17 ISO 13485 §5.6 inputs | Combined Agenda + Minutes template covering all 17 ISO 13485 §5.6 inputs | €69 | View → |
| MDSAP | 🔧 Core | Internal AuditAnnual Programme + Audit Plan + Audit Report with MDSAP coverage tracking | Annual Programme + Audit Plan + Audit Report with MDSAP coverage tracking | €69 | View → |
| MDSAP | 🔧 Core | CAPA11-page combined template covering all stages: Initiation, RCA, Effectiveness, Closure | 11-page combined template covering all stages: Initiation, RCA, Effectiveness, Closure | €69 | View → |
| MDSAP | 🎯 Program Mgmt | MDSAP Program ManagementMaster MDSAP program SOP. Ties together all 5 jurisdictions with audit cycle | Master MDSAP program SOP. Ties together all 5 jurisdictions with audit cycle | €69 | View → |
| MDSAP | 🇧🇷 Brazil · Marketing Auth | Brazil Marketing AuthorizationANVISA registration SOP + Classification + Pathway Decision per RDC 751/2022 | ANVISA registration SOP + Classification + Pathway Decision per RDC 751/2022 | €69 | View → |
| MDSAP | 🇯🇵 Japan · Marketing Auth | Japan Marketing AuthorizationPMDA registration SOP + JMDN Classification + Pathway template (Shonin/Ninsho/Todokede) | PMDA registration SOP + JMDN Classification + Pathway template (Shonin/Ninsho/Todokede) | €69 | View → |
| MDSAP | 🇨🇦 Canada · Marketing Auth | Canada Marketing AuthorizationHealth Canada MDL/MDEL SOP + Classification + MDL Application Checklist | Health Canada MDL/MDEL SOP + Classification + MDL Application Checklist | €69 | View → |
| MDSAP | 🇦🇺 Australia · Marketing Auth | Australia Marketing AuthorizationTGA ARTG inclusion SOP + Conformity Assessment Pathway. 5 pathways covered | TGA ARTG inclusion SOP + Conformity Assessment Pathway. 5 pathways covered | €69 | View → |
| MDSAP | 🇺🇸 USA · Marketing Auth | USA Marketing AuthorizationFDA pathway SOP + Pathway Selection + Substantial Equivalence Matrix (510k/De Novo/PMA) | FDA pathway SOP + Pathway Selection + Substantial Equivalence Matrix (510k/De Novo/PMA) | €69 | View → |
| MDSAP | 🇧🇷 Brazil · Vigilance | Brazil Vigilance ReportingANVISA Notivisa SOP + Brazilian Reportability Decision Worksheet | ANVISA Notivisa SOP + Brazilian Reportability Decision Worksheet | €69 | View → |
| MDSAP | 🇯🇵 Japan · Vigilance | Japan Vigilance ReportingPMDA vigilance SOP + Japanese Reportability Decision Worksheet (PMD Act Art. 68-10) | PMDA vigilance SOP + Japanese Reportability Decision Worksheet (PMD Act Art. 68-10) | €69 | View → |
| MDSAP | 🇨🇦 Canada · Vigilance | Canada Vigilance ReportingHealth Canada MPR + FRN SOP + combined worksheet (SOR/98-282 §59) | Health Canada MPR + FRN SOP + combined worksheet (SOR/98-282 §59) | €69 | View → |
| MDSAP | 🇦🇺 Australia · Vigilance | Australia Vigilance ReportingTGA MDIR SOP + Exemption Justification Worksheet (TG MD Regulations 2002) | TGA MDIR SOP + Exemption Justification Worksheet (TG MD Regulations 2002) | €69 | View → |
| MDSAP | 🇺🇸 USA · Vigilance | USA Vigilance ReportingFDA MDR SOP + FDA MDR Reportability Decision Worksheet (21 CFR Part 803) | FDA MDR SOP + FDA MDR Reportability Decision Worksheet (21 CFR Part 803) | €69 | View → |
| EU MDR 2017/745 | 🫓 Clinical & PMS | Clinical Evaluation Plan (CEP)Word template per EU MDR Art. 61 + Annex XIV-A. PICO, equivalence, GSPR mapping | Word template per EU MDR Art. 61 + Annex XIV-A. PICO, equivalence, GSPR mapping | €69 | View → |
| EU MDR 2017/745 | 🫓 Clinical & PMS | Clinical Evaluation Report (CER)Word template per EU MDR Art. 61 + Annex XIV-A. Companion to CEP, NB-ready | Word template per EU MDR Art. 61 + Annex XIV-A. Companion to CEP, NB-ready | €69 | View → |
| EU MDR 2017/745 | 🫓 Clinical & PMS | Clinical Development Plan (CDP)Word template per Annex XIV-A. Residual uncertainties, GSPR cluster, RWD strategy | Word template per Annex XIV-A. Residual uncertainties, GSPR cluster, RWD strategy | €69 | View → |
| EU MDR 2017/745 | 🫓 Clinical & PMS | PMS Plan (MDR)Word template per EU MDR Art. 83-84 + Annex III §1.1. MDCG 2022-21 aligned | Word template per EU MDR Art. 83-84 + Annex III §1.1. MDCG 2022-21 aligned | €69 | View → |
| EU MDR 2017/745 | 🫓 Clinical & PMS | PSUR (MDR)Word template per EU MDR Art. 86. Every 2 years (IIa) or annual (IIb-III) | Word template per EU MDR Art. 86. Every 2 years (IIa) or annual (IIb-III) | €69 | View → |
| EU MDR 2017/745 | 🫓 Clinical & PMS | PMCF PlanWord template per EU MDR Art. 61(11) + Annex XIV-B. MDCG 2020-7 aligned | Word template per EU MDR Art. 61(11) + Annex XIV-B. MDCG 2020-7 aligned | €69 | View → |
| EU MDR 2017/745 | 🫓 Clinical & PMS | PMCF Evaluation ReportWord template per Annex XIV-B. Activities executed, integrated analysis. MDCG 2020-8 | Word template per Annex XIV-B. Activities executed, integrated analysis. MDCG 2020-8 | €69 | View → |
| EU MDR 2017/745 | 🫓 Clinical & PMS | SSCPWord template per EU MDR Art. 32. Class III + implantables. Eudamed-ready | Word template per EU MDR Art. 32. Class III + implantables. Eudamed-ready | €69 | View → |
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