Clinical Evaluation — Process Package (ISO 13485)
€69.00Clinical Evaluation SOP with CEP and CER templates. Aligned with EU MDR Annex XIV + MDCG 2020-5 (equivalence) + MDCG 2020-13 (CEAR).
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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.
