Madhu R's Linkedin Analytics

A certified Medical device Regulatory Affairs Professional and a Registered Pharmacist graduated as Master in Pharmaceutical quality assurance graduate (2019- 2021). Currently working as "Medical Device Regulatory Affairs Associate" @ "Vphore Labs Pvt. Ltd (Infraeyes)". Involved in following responsibilities like: Authoring high-quality dossier documents preparation for Medical equipment's like device master file, site master file, SOP's of various equipment's used in the manufacturing process, customer feedback analysis, ISO 13485: 2016 i.e., Quality Management System for medical device, EN ISO14971: 2019 i.e., application of Risk Management to Medical Device, SOP: Standard Operating Procedure, ISO: International Organization for Standardization, EU MDR, UDI ID, and EUDAMED.