Yashaswini Patwardhan

Client is located in the Munich area and is a medical device manufacturer. Project involves creation of Summary technical file documentation (STED) for numerous products related to dialysis treatment including dialysis machines, haemodialysis concentrates and tubing sets. Creation of a MDR compliant STED for a class III sterile priming solution. Assessment of infusion pump system technical files for EU MDR compliance and propose remediation plan to address gaps for a client located in San Diego CA.

Provide consulting services for QMS remediation in the areas of post market surveillance (CAPA's, complaint handling, MDR reporting) for a client company manufacturing heart lung machines and other on-pump cardiac surgery devices. Subject Matter Expert services on risk management process improvements for a client company manufacturing auto injector devices.

Lead quality engineer on the risk management team responsible for creation, update and maintenance of the risk management file and risk management process. Risk management and quality engineering representative on a team leading changes to design based on usability study results.