Prem Narayan Pandey Email and Phone Number

Thank you for taking the time out to read my profile: I'm Prem Narayan Pandey, an accomplished medical device professional with over 13+ years of experience in the clinical and regulatory field of the medical device industry. Throughout my career, I have successfully filed a multitude of medical devices in Europe, ensuring strict adherence to regulatory requirements. As an expert in the dynamic landscape of the MDR, I excel at navigating its complexities with finesse. Currently, I hold a pivotal role in spearheading the submission process for medical devices in Europe, seamlessly incorporating MDR updates. With my extensive expertise, I have honed my skills in preparing meticulous technical files, implementing robust Risk Management Processes (ISO 14971), crafting compelling Clinical Evaluation Reports (CERs), and developing effective Post-Market Surveillance (PMS) strategies and PMCF across a range of medical device classes, including Class I, IIa, IIb, and III. I have also helped CROs and consulting firms in acquiring ISO 14155 certification.