CMC Technical Writing: A Critical Enabler During Product Development
Roderick Shilshi
25 Jun, 2025
Roderick Shilshi is a regulatory medical writer specializing in medical device compliance under FDA and EU MDR regulations. He has experience authoring Clinical Evaluation Reports (CER), Post-Market Surveillance Reports (PMSR), and Risk-Benefit Assessments, ensuring alignment with MEDDEV 2.7/1 Rev. 4 and MDR standards.
With expertise in literature reviews, safety reporting, and regulatory submissions, he supports product lifecycle management and clinical data analysis. His detail-oriented approach helps maintain compliance and streamline regulatory documentation.
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