Clinical Evaluation Plan — AI-Augmented (AI-08a)
€69.00A clinical evaluation plan on a real CEP template, with AI-specific additions flagged as [AI MODULE] for integration with your clinical process.
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Clinical Evaluation Report — AI-Augmented (AI-08b)
€69.00The reporting counterpart to AI-08a on a real CER template with [AI MODULE] markers, documenting the AI clinical evidence and benefit-risk contribution.
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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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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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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.
