Beyond Document Delivery: How a Compliance-First CER Strategy Helped Achieve a Successful Notified Body Review
Priya Ray Chaudhuri
25 Aug, 2025
Priya Ray Chaudhuri has over 11 years of experience in the Life Sciences industry with a strong focus on regulatory medical writing and clinical evaluation for medical devices. She has extensive experience in authoring and reviewing EU MDR compliant regulatory documents, including Clinical Evaluation Plans (CEP), Clinical Evaluation Reports (CER), and Post-Market Surveillance (PMS) documentation across a wide range of therapeutic areas.
At Celegence, she leads a team of qualified medical writers and SMEs providing strategic guidance to customers on regulatory strategy for clinical evaluation, clinical evidence generation, and post-market surveillance activities including Post-Market Clinical Follow-up (PMCF). She has successfully managed several projects related to clinical evaluation of simple-to-complex medical devices and addressing observations from Notified Bodies clinical review.
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