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.
Showing all 9 results
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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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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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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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Summary of Safety and Clinical Performance (SSCP) Template – MDR
€69.00Word template for the SSCP per EU MDR Article 32. Required for Class III and implantable devices, suitable for Eudamed publication.
