EU MDR Consulting

Dr. Pratibha has a Master’s degree in Oral Medicine and Maxillofacial Radiology and has previously worked in academia and healthcare.

Specializes in clinical evaluation of simple-to-complex medical devices, including combination products, and medical device software. She is a BSI-certified expert on regulatory strategy for Clinical Evaluation, Risk Management, PMS including PMCF, and Clinical Evidence pathways for medical devices.

Has authored and reviewed templates and regulatory documentation for medical devices covering a wide range of therapeutic areas – dentistry including implantology, ophthalmology, diagnostic imaging, interventional radiology, general and electrosurgery, nephrology and dialysis, gastroenterology, thoraco-pulmonology, cardiovascular, female reproductive health, wound care, esthetic surgery, instrument reprocessing systems, and specimen management.

Her team of highly qualified medical writers and SME at Celegence has successfully completed several projects on addressing Notified Body observations (BSI, DEKRA, Intertek, SGS, Eurofins, TUVSUD) on the road to CE Marking of medical devices under EU MDR. Her team also handles clinical and regulatory consulting, documentation, and intelligence for other countries/regions such as USA, UK, Canada, Australia, South-East Asia, Saudi Arabia, China and other countries/regions across the globe.

Dr. Ipshita Chattopadhyaya is a results‑driven Regulatory Affairs and Clinical Safety professional with over 8 years of experience supporting global clients in CE marking, EU MDR compliance, and lifecycle management of medical devices, combination products, and pharmaceuticals.

She provides strategic SME guidance across diverse international markets, enabling timely certification and sustained regulatory compliance. Her expertise spans Class I–III medical devices, including insulin delivery systems, defibrillators, surgical instruments, catheters and cannulas, respiratory care devices, orthopedic implants, combination and ophthalmic products. She is highly experienced in EUMDR‑aligned clinical evaluation, systematic literature reviews, risk management, post‑market surveillance, and high‑quality regulatory documentation, with additional strength in PSUR and ICSR reporting for FDA‑regulated drugs, ensuring adherence to stringent global timelines and quality standards.

In Celegence, she mentors multidisciplinary teams to deliver complex regulatory projects efficiently. Known for her strong client engagement skills, she consistently balances strategic oversight with hands‑on execution, fostering a culture of collaboration, accountability, and continuous learning. Ph.D.‑qualified in Pharmaceutical Sciences, with publications in peer‑reviewed journals, Dr. Chattopadhyaya is a trusted advisor to clients on regulatory strategy, compliance risk mitigation, and successful market access.

Dr. Anushree Singh has a Doctorate degree in Neuro-oncology and a Master’s degree in Bioscience (Human Genetics). She has 13 years’ experience in the Life Sciences Industry including 5 years’ experience in Regulatory Writing for Medical Devices. She has authored and reviewed EU MDR compliant regulatory documents for medical devices covering a wide range of therapeutic areas.

At Celegence, she provides strategic advice to customers on regulatory strategy for clinical evaluation, Post-Market Surveillance (PMS) 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.

Smridula holds a Master’s degree in Pharmacy and brings 13+ years of experience in medical device regulatory writing, pharmacovigilance, and clinical research.

She supports global manufacturers across MDR and IVDR compliance through strategic regulatory and safety expertise.

Smridula provides deep expertise in safety database analysis, signal detection, and complaint handling to support regulatory compliance and patient safety.

Joseph has 20 years experience in medical device life cycle management and quality management systems (certified to ISO 13485, ISO 9001 & ISO/IEC17025).

Key experience includes preparation and maintenance of technical files, product safety and vigilance reporting, clinical evaluations, risk assessment, regulatory audits, CE and notified body opinion submissions.

Joseph has worked on diabetes management devices, nicotine replacement therapy (NRT) devices and pressurised metered dose inhalers (pMDI); Joseph has worked for small, medium and large Biotech companies such as Roche, OBG Pharmaceuticals and Kind Consumer Ltd.