Bijayata Upadhyay
Principal Regulatory Consultant
I joined Advena in 2021 as a Regulatory Consultant. My role involves assisting clients with regulatory
queries and preparation of technical documents and files for medical devices [Class I to Class IIa]. My
expertise lies in risk management, clinical evaluation, useability, claims compliance and standard
compliance determination.
I have worked in medical device regulatory affairs since 2011 and during these years I have managed
to gain extensive insights and know-how of medical device regulatory field. My past experiences
include preparation of regulatory documents for breast implant, orthopaedic implants, dialysis
machines and catheters.
