Jiwan Medical Inc.

Working with medical device companies to generate clinical evaluations for class I-III devices that comply with MEDDEV 2.7/1 rev. 4 and EU Medical Device Regulation 2017/745 (EU MDR). Examples of documents include: - Clinical Evaluation Plan (CEP) - Clinical Evaluation Report (CER) - Post Market Clinical Follow-up Plan (PMCF Plan) and Report (PMCFER) - Summary of Safety and Clinical Performance (SSCP) - Periodic Safety Update Report (PSUR) Other documents include: - Protocols - Clinical Study Reports (CSR) - Publications

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