Beyond Document Delivery: How a Compliance-First CER Strategy Helped Achieve a Successful Notified Body Review
Tamanna Sahraya
25 Jun, 2025
Tamanna Sahraya is a skilled medical writer specializing in regulatory documentation for medical devices, with expertise in FDA and EU MDR compliance. She has experience authoring Clinical Evaluation Reports (CER), Post-Market Surveillance Reports (PMSR), and Risk-Benefit Assessments while ensuring adherence to MEDDEV 2.7/1 Rev. 4 and MDR standards.
With a strong background in regulatory affairs, literature reviews, and safety analysis, she supports product lifecycle management and clinical data reporting. Her analytical approach and commitment to compliance help streamline regulatory submissions and enhance client collaboration.
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