Katylistic GmbH provides regulatory writing and clinical evaluation services for medical device manufacturers, focusing on clinical evaluation reports, post‑market clinical follow‑up (PMCF) activities, and workshops to improve documentation processes.
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Industry:Technical Consulting & Engineering
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Strategy and documentation for MDR-compliant clinical evaluations, including the Clinical Development Plan, Clinical Evaluation Plan, Literature Search Plan and Report, state-of-the-art evaluation and Clinical Evaluation Report.
Post-Market Clinical Follow-Up (PMCF)
PMCF strategies and documentation with literature searches, user surveys, registry strategies, PMCF investigations, real-world evidence approaches and PMCF evaluation report.
Workshops
Interactive workshops on clinical evaluation, PMCF, state-of-the-art evaluations, SSCP preparation, medical device software including AI/ML devices and good medical writing practice.
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