Ashwini Lingappa Swamy

• Conducted technical file reviews in accordance with Medical Device Regulation (EU) 2017/745 for Class IIa/IIb devices within defined time frames.
• Supported CE marking activities by assisting sales and scheduling teams with technical queries.
• Ensured adherence to DNV policies, procedures, and processes.
• Communicated effectively with team members and clients regarding product assessments and other activities.
• Managed the operational interface between DNV Market Unit and accreditation/regulatory bodies.
• Sustained effective working relationships with clients and within the team.
• Established an effective and uniform approach for performing assessment of technical documentation as per Section 4 of Annex IX of Medical Device Regulation.
• Detailed the process for assessing changes to certified devices and systems as required by the MDR, UK MDR, and accreditation requirements.
• Specified activities to be performed based on the nature of the change.
• Assessed changes on MDSAP Certification, determined necessary actions, and notified regulatory authorities accordingly.
• Handled the Vigilance cases reported to Notified/Approved Bodies (or obtained from Competent Authorities/ Eudamed) are evaluated to estimate their impact on the validity of MDD or MDR certificates issued by DNV PA.
• Established a dedicated mailbox for receipt of vigilance cases at the Market Unit (MU) level, ensuring customers are informed of the contact details for streamlined registration and assessment of vigilance cases.
• Registered vigilance cases in the production system, including all received or requested documentation.
• Verified Certification Proposal (CP) details to identify the device and correct MDR, MDD, or MDT codes, recording these in the vigilance case description.
• Reopened and updated vigilance cases with supplementary information as needed.
• Allocated registered vigilance cases to the appropriate auditor or assessor for further assessment
• Conduct thorough assessments of medical devices technical documentation to ensure compliance with regulatory standards and requirements
• Collaborate with cross-functional teams to review and approve documentation for new product submissions and changes to existing products
• Utilize expertise in medical device regulations and standards to provide guidance and support to internal stakeholders
• Maintain accurate records and documentation of assessment activities, findings, and decisions
• Generated [#] [metric] in [#] [months, quarters, years], exceeding goal by [%]
• Provide guidance and support to internal teams on documentation requirements and best practices for MDR assessments
• Collaborate with cross-functional teams to address deficiencies in technical documentation and drive timely and effective resolutions
• Conduct comprehensive reviews of medical devices technical documentation to ensure compliance with relevant regulations and standards

Key Contribution For 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

Key Contribution for Verification & Validation :

• Developed & executed Test Cases for Software Requirements and Product Requirements
• Developed System Verification Plan and System Validation Plan Prepared Endurance Test cases for Silicon material and identified the lab which supports in developing Jigs and fixtures for endurance test.
• Providing effective oversight to Risk Management process activities, and of all design-related activities during product development.
• Led V&V activities for medical device software, ensuring compliance with regulations.
• Developed test plans and protocols for software verification and validation.
• Conducted risk analysis to identify and mitigate potential issues during V&V.
• Managed team of software testers to ensure timely and accurate V&V testing.
• Lead V&V activities, ensuring compliance with industry standards and project requirements.
• Manage team of engineers, coordinating test plans and execution for system validation.
• Develop test strategies, cases, and scripts for software and hardware verification.
• Conduct reviews and audits to identify and resolve issues, improving product quality.
• Lead V&V activities, ensuring compliance with industry standards and project requirements.
• Developed and implemented test strategies, plans, and procedures to validate complex software systems for critical applications
• Coordinated with cross-functional teams to identify and resolve issues during the verification and validation process
• Managed the creation and execution of test cases, scripts, and scenarios to verify system functionality and performance
• Established metrics and reporting mechanisms to track progress and communicate status updates to key stakeholders

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

• 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.
• Managed and led cross-functional teams to implement new medical device compliance procedures
• Collaborated with colleagues to troubleshoot technical issues and implement innovative solutions.
• Provided training and support to non-technical staff on new software and hardware systems.
• Conducted research to stay current on industry trends and emerging technologies for recommendations.
• Developed technical solutions for customer inquiries, improving efficiency and customer satisfaction.
• Collaborated with cross-functional teams to develop and execute project plans to meet business objectives and deadlines

Agile Development

• Gathered Sprint requirements, distributed tasks among team members, identified impacted areas, and developed acceptance criteria.
• Developed test cases for each story in the sprint.

Key Contributions in Quality

• Managed quality for all Sprint stories and conducted Validation Readiness Reviews.
• Maintained comprehensive documentation, including review reports and Requirement Traceability Matrices.

Post Market Surveillance and Risk Management

• Conducted risk assessments for software changes in existing Power Injectors as per ISO 14971 standards.
• Prepared Risk Management Plans and Reports for Power Injectors used in radiology devices (e.g., CT Scanners, MRI).
• Developed Post-Market Surveillance Plans and Reports, consolidating customer complaint analysis, MAUDE Database, Adverse Events, DeviceRecall, CAPA Info, and Design Changes.
• Ensured effective utilization of data to drive improvements 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.

In Testing:

• Developed & executed test cases for Patient Monitoring System and Central Nursing Station as per Software requirements and Product Requirements.
• Developed Verification and Validation Plans Prepared and executed Accuracy test plan for vital parameters like ECG, SpO2, NIBP, IBP, RESP & TEMPRATURE
• Responsible for updating existing test cases based on requirement analysis
• Performing Sanity Testing, and Regression testing for newly released builds
• Defect Reporting and Defect Tracking throughout the life cycle
• Conducted Clinical Trials for the Patient Monitoring System

• Mysore
• Worked as Apprentice Trainee in Quality Certification department
• Checking the quality of outgoing product (PCB’s).
• Verifying the product quality against customer specification & IPC standards.
• Updating the documents as per TS &ISO standards.
• Updating product inspection information in SAP.
• Prepared the team for the internal audit.