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Anushree Singh

Associate Manager, Medical Device Services
Celegence

Dr. Anushree Singh has a Doctorate degree in Neuro-oncology and master’s degree in Bioscience (Human Genetics), and an overall experience of 6 years working as a researcher and lecturer, and 4.5 years in the medical devices industry.

She has authored and reviewed EU MDR compliant regulatory documents for medical devices covering a wide range of therapeutic areas – all specialties of dentistry, radiosurgery, diagnostic imaging, neuro-oncology, hemodialysis, female reproductive health, and pneumothorax pulmonology.

At Celegence, she provides strategic advice to customers on regulatory strategy for clinical evaluation, Post-Market Surveillance (PMS) including Post-Market Clinical Follow-up (PMCF), and Clinical Evidence pathways. She leads a team of qualified medical writers, expert in clinical evaluation of simple-to-complex medical devices, authoring various regulatory documents such as Clinical Evaluation Plans and Reports, PMS Plans and Reports, Summary of Safety and Clinical Performance, and PMCF Plans. Her team has successfully completed several projects related to addressing Notified Body observations (BSI, DEKRA, SGS, Eurofins Expert Services Oy) on the road to CE Marking of medical devices under EU MDR.

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