Ashwini Lingappa Swamy

Key Contribution To Quality

• Developed Quality System Procedures and Templates along with guidelines for Design & Development, Verification & Validation, Defect Management and Change management process
• Conducted Internal Audit and Supplier audit in compliance with ISO 13485:2016 - Responsible for performing and following up on internal/supplier audit program
• Confronted External Audit (ISO13485) - Supported auditors in effective and efficient execution and documentation, investigation, impact assessment, and corrective/preventive action
• Review of documents (viz: DFMEA, Test Spec, Test report) received from suppliers

Key Contribution To Risk Assessment

• Contributed to Risk assessment by identifying potential risks
• Identified & Verified the test cases in accordance with the risk Assessment
• Ensured that all risk measures (design, User manual, label) are implemented properly by verification.
• Providing effective oversight to Risk Management process activities, and of all design-related activities during product development.
• Risk Assessment before each phase of clinical trials

Key Contribution for Verification & Validation:

• Developed & executed Test Cases for Software Requirements and Product Requirements
• Developed System Verification Plan/Report and System Validation Plan/Report
• Prepared Endurance Test cases for Silicon material and identified lab which supports in developing Jigs and fixtures required for endurance test
• Developed Test cases for RESPIRATION parameter measured by using EMG signals algorithm
• Developed Traceability Matrix
• Identified tests to be executed in the manufacturing process
• Ensured process validation is executed at suppliers
• Ensured all the tools (hardware & software) used at the supplier for testing and manufacturing
• Reviewed all the documents from the supplier (Requirements, test plan, test report, DFMEA) and provided feedback on the correction required.
• Review of Clinical evaluation plan, report and prepared test protocols for Clinical evaluation
• Prepared Test protocol for First In Men Studies (FIM) with Risk assessment
• Coordinated with external labs for Safety testing (IEC 60601-1), ISTA testing

Key Contribution for Philips in Q& R group (Supported Service Platform Projects)

• Ensured that Service Platform Projects complied with QMS, as per Philips's policy & standards for all the New Product development and changes to the existing product
• Worked with multiple stakeholders to ensure Intra Company Quality Agreements (ICQA) requirements are established, met and ICQAs maintained
• Responsible for Quality Plan preparation and Milestone Review activities for assigned products, timely resolution of non-conformities, issuing and/or monitoring corrective actions associated with non-conformance and deviations
• Assisted in maintaining design history files, Good Documentation Practice (GDP), adhering to design control procedures
• Reported progress and status of assigned projects on a timely basis by maintaining KPI.

QARA (Quality and Regulatory) group,

Client: Draeger

Key Contribution in Verification:

• Developed & executed test cases for Patient Monitoring System and Central Nursing Station as per Software requirements and Product Requirements
• Developed and executed accuracy test plan for vital parameters like ECG, SpO2, NIBP, IBP, CO, RESP & TEMP
• Developed & executed test cases for Patient Monitoring System which supports Defibrillator, Pacemaker, anesthesia machines, Infusion Pump, Ventilators,
• Developed & executed test cases for Patient Monitoring System which uses External Software
• Developed & Executed the test cases for Central Nursing Station which is software alone installed on the Computer which monitors the 16 to 64 patient Monitoring system (Wired connection and wireless)
• Performed safety and risk assessments, facilitating product verification reporting to effectively assure product quality and to mitigate potential compliance risks.
• Writing test cases for CAPA activity and ensuring that the CAPA is closed with all required documents.
• Defect Reporting and Defect Tracking throughout the life cycle

Key Contribution in Quality:

• Involved in Quality Management for all Sprint stories & Validation Readiness Review by maintaining good documentation, Review report, (Application of usability engineering) Requirement Traceability Matrix

Key Contribution in Post Market Surveillance and Risk Management Activity:

Client: Bayer

• Hands on Experience with the Power Injectors used in CT machines(MEDRAD® Stellant)
• Experience in Post Market Surveillance activity with the Power Injectors used in MR machine & CT Machine
• Conducted Risk Assessment for Software enhancement of Power Injectors as per ISO 14971 standard
• Prepared Risk Management Plan, Report
• Prepared Post-market surveillance plan & report for Power Injectors by consolidating customer complaint analysis, MAUDE Database, Adverse Events, Device Recall, CAPA Info, and Design Changes and ensured an effective utilization of data to drive dedicated improvements in the team and maintained an audit-ready state
• Was responsible for planning and organizing resources cross-functionally to achieve project goals and objectives (Risk Management Plan, Program/Project Plan, Schedule) to effectively mitigate risks and provide clear direction.
• Technical File reviewer for 510K submission
• As follow up action, ensured the test scenario missed as per the post market surveillance activity is added in the main test protocol and design team did a feature enhancement

Key Contribution in Verification:

• Developed & executed test cases for Patient Monitoring System and Central Nursing Station as per Software requirements and Product Requirements
• Developed & executed Test Cases for Wireless ,HL7 testing
  • Developed and executed accuracy test plan for vital parameters like ECG, SpO2, NIBP, IBP, CO, RESP & TEMP
  • Developed & executed test cases for Patient Monitoring System which supports Defibrillator, Pacemaker, anesthesia machines, Infusion Pump, Ventilators, Electrosurgical instrument Cauterization devices
• Developed & executed test cases for Patient Monitoring System which uses External Software
• Developed & Executed the test cases for Central Nursing Station which is software alone installed on the Computer which monitors the 16 to 64 patient Monitoring system (Wired connection and wireless)
• Designed and executed the test cases for Wired (WLAN) communication Viz: How the communication between PMS and CNS happens with HUB and without HUB Ensured that no patient data can be hacked by external network
• Designed and executed the test cases for Wireless communication Viz: How the communication between PMS and CNS happens with Wireless, distance of the Wireless communication, IP address conflict, Interference and hacking of Patient data
• Designed and executed the test cases for HL7 communication Viz: How the Patient data is transferred from PMS to CNS and vice versa.
  Ensuring that no patient data can be transferred to the third party devices.
  Ensuring that no patient data can be hacked
  Performed safety and risk assessments, facilitating product verification reporting to effectively assure product quality and to mitigate potential compliance risks.
• Writing test cases for CAPA activity and ensuring that the CAPA is closed with all required documents.
• Defect Reporting and Defect Tracking throughout the life cycle
• Coordinated with external test labs (Safety and Performance Test Labs) and witnessed the test
• Developed and executed the test cases for the power supply used in the patient monitor system

Key Contribution in Validation:

• Developing Validation plan & report for the product
• Responsible for conducting clinical trials and providing the feedback to the R&D team
• Developing & executing the Validation test cases (IQ, OQ & PQ) for the Jigs & fixtures and software which is developed in-house used in the Verification & Manufacturing process.