Clinical Development Plan (CDP) Template – MDR
€69.00Word template for the Clinical Development Plan per EU MDR Annex XIV Part A. Critical for Class III and implantable devices.
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Clinical Evaluation Plan (CEP) Template – MDR
€69.00Word template for the Clinical Evaluation Plan, aligned with EU MDR Article 61 and Annex XIV-A. Includes PICO, equivalence, state-of-the-art search and GSPR mapping.
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Clinical Evaluation Report (CER) Template – MDR
€69.00Word template for the Clinical Evaluation Report, aligned with EU MDR Article 61 and Annex XIV-A. Companion to the CEP, structured for Notified Body review.
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Design FMEA (dFMEA) Template – MDR
€69.00Active Excel template for Design FMEA aligned with EN ISO 14971:2019/A11:2021. Auto-calculated RPN, automatic Region classification (Acceptable / AFAP / Unacceptable), conditional formatting and three worked examples.
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EU MDR Clinical Documentation Kit
€399.00Audit-ready clinical and post-market documentation kit for EU MDR (Regulation 2017/745). 8 editable Word templates: CEP, CER, CDP, PMS Plan, PSUR, PMCF Plan, PMCF Evaluation Report, SSCP.
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EU MDR Technical Documentation Kit
€429.00The complete Annex II technical file for EU MDR (Regulation 2017/745) in one coordinated set. Eight professionally drafted Word templates from Device Description to Declaration of Conformity, with Team-NB position papers integrated. Ready for Notified Body submission.
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GSPR Checklist Template – MDR
€69.00Operational Excel checklist covering all 159 General Safety and Performance Requirements of MDR Annex I. Filterable, with applicability dropdown and color-coded compliance status.
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Hazard Analysis (HAN) Template – MDR
€69.00Word template for the Hazard Analysis implementing the full ISO/TR 24971:2020 Annex A questionnaire (46 questions). Systematically identifies hazards across the device lifecycle.
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MDR Complete Bundle
€999.00The complete EU MDR documentation set in one premium bundle. Three coordinated kits covering technical file, clinical evaluation and risk management. 22 templates total. Save 15% vs buying separately.
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Periodic Safety Update Report (PSUR) Template – MDR
€69.00Word template for the PSUR per EU MDR Article 86. Every 2 years for Class IIa, annual for Class IIb and IIII.
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PMCF Evaluation Report Template – MDR
€69.00Word template for the PMCF Evaluation Report per EU MDR Annex XIV Part B. Documents the outcomes of executed PMCF activities.
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PMCF Plan Template – MDR
€69.00Word template for the Post-Market Clinical Follow-up Plan, aligned with EU MDR Article 61(11) and Annex XIV Part B.
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Post-Market Surveillance (PMS) Plan Template – MDR
€69.00Word template for the Post-Market Surveillance Plan, aligned with EU MDR Articles 83-84 and Annex III Section 1.1.
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Risk + Clinical Documentation Bundle – MDR
€599.00Save 20% by buying the Risk Management Documentation Kit and the EU MDR Clinical Documentation Kit together. Fourteen coordinated templates covering both halves of MDR Annex II in one purchase.
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Risk Management Documentation Kit – MDR
€349.00The complete risk management documentation kit aligned with EN ISO 14971:2019/A11:2021, IEC 62366-1 and EU MDR Annex I. Six coordinated templates: Risk Management Plan and Report, Hazard Analysis, Design FMEA, Use-related FMEA and General Safety and Performance Requirements Checklist. Save 16% vs buying individually.
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Risk Management Plan (RMP) Template – MDR
€69.00Word template for the Risk Management Plan per EN ISO 14971:2019/A11:2021. Defines the process, scoring scales, acceptability thresholds and competence matrix. The framework all other risk documents reference.
