Rupal N.

Design Control in Medical Device Risk Management in Medical Device Risk Management in Combination products Usability testing in medical device and combination products

Research and Development-Combination Product and Medical Device

New product development - feasibility prototypes (class ll and lll Neuro and Peripheral medical devices) - Design and build functional prototypes to demonstrate technical feasibility of intended product - Feasibility testing - Animal study - Usability testing - Design Control - Biocompatibility testing - ISO 10993 - Beta testing

New product development - class lll medical devices from idea phase to commercialization phase Design Control Activities Risk Management- ISO 14971 & Usability Std. Usability Testing Beta Testing / Clinical Cases Sterilization Validation Test Method Validation Biocompatibility testing - ISO 10993 Manufacturing Transfer Activities

NPD projects from concept to manufacturing transfer (5 Projects) Design Control Verification and Validation activities Risk Management External Manufacturer and supplier Technical Assessment and Audit

Management Reviews Risk Management CAPA ,NCR, Customer Experience Product Evaluation Design Control Validations Audits

Provided engineering support in a manufacturing environment. responsible for product & process design, quality, reliability and performance while maintaining GMP, safety, cost containment and cost reduction to ensure timely product delivery to the customer.