Darshit Makawana

Leading QARA strategy for a portfolio of AI/ML-based SaMD, clinical decision support, and companion diagnostic products across US and EU markets. Currently focused on scaling an AI-native quality function embedding automation into core QARA workflows while keeping human judgment at the center of every critical decision.

As a key leader, I architect and direct the quality and regulatory foundation for PathAI's portfolio of AI-powered Software as a Medical Device (SaMD) and Clinical Development Services (CDS) products, guiding them from inception through post-market success. •Strategic Leadership & Team Management: I lead, mentor, and develop a high-performing team of product quality and regulatory affairs specialists, managing departmental OKRs, budget, and professional growth to align with company goals. I also serve as the primary liaison to executive leadership, establishing key stakeholder relationships and communicating progress on all strategic initiatives. •Product Quality & Compliance: I drive the overarching strategy for product quality, streamlining development processes for SaMD/CDS products and embedding Agile methodologies within regulated frameworks (SDLC, Risk Management). I act as the subject matter expert (SME) during customer visits and successful external audits (ISO/MDSAP), ensuring robust compliance across all phases of development and product release. Additionally, I oversee the company-wide Software Tool Validation Program. •Regulatory Affairs: I develop and execute the global regulatory strategy for products in new and existing markets, providing risk-based recommendations and managing pre-market submissions and communications with regulatory bodies. My responsibilities also include managing all post-market regulatory activities, such as complaint evaluation for reportability, recall planning, and ensuring marketing materials are compliant. I also serve as the lead regulatory representative in strategic BioPharma partnerships (CDx, CDS).

Product Development Activities • Provide quality support to new and sustaining product development teams that focus on development of Sequencing instrumentation software technology to develop high standard regulatory compliant medical devices/IVD products. This involves developing products that align with US FDA and other regulatory policies • Ensuring teams adhere to design control activities per 21 CFR 820, ISO 13485, IEC 62304 and related standards. This includes, but not limited to, software design, implementation, software verification, validation, risk management, configuration management and deployment activities • Provide trainings on product development life cycle and risk management to developers, testers and other stakeholders within the organization • Lead and participate in the product risk management activities per ISO 14971 • Ensure quality and completeness of design history files • Provide quality voice to technical software discussions and risk-based decision making Post Market and Quality System Activities • Participate in supporting audits/inspections from regulatory or notified bodies for products developed at Illumina including Sequencing instrumentation technology • Support post market activities related to product anomalies - Complaint Handling, MDR’s, CAPAs – and ensure activities are handled per Illumina’s processes • Provide inputs to continuous improvements initiatives to develop compliant processes • Trend, analyze, and report on quality data to improve product and process

• Developed IQ/OQ/PQ protocols for laboratory instruments and manufacturing equipment • Generated Validation Master Plans for qualification of laboratory instrument software. • Generated software assessments for laboratory instruments including HiSeq Genomic Sequencing Instruments • Ensured all systems operate within strict FDA regulations as 21 CFR Part 11, Data Integrity and GAMP 5 • Developed user requirements for laboratory instruments.

- Identified USC research capabilities in specific industry sectors such as healthcare, artificial intelligence, internet of things and virtual reality - Analyzed industry trends and technological needs for mapping USC research capabilities to industry opportunities - Evaluated potential market opportunities of technologies and their value proposition in the given market - Tailored 4 individual, non-confidential marketing document of USC’s inventions to assist with marketing the inventions to potential industrial partners

- Performed verification and validation of software applications for Molecular Diagnostics Instruments such as -Panther System - Executed manual and automated test cases using HP Quality Center (QC) in following areas: functional, system, integration, risk mitigation, database(SQL), negative and user acceptance testing. - Designed and executed IQ, OQ and PQ protocols and reports - Performed detailed data analysis of stress and regressing test to identify defects software bugs - Recreated field reported issues in the lab environment to troubleshoot and analyze root cause - Reviewed Software Requirements Specification (SRS) and Product Requirements Document (PRD) - Designed and updated test cases based on the requirements analysis for medical device. - Performed bug reporting and bug tracking throughout its life cycle using a web-based tool - PTC Integrity (MKS) - Examined changes based on Software Change Request (SCRs) and Software Change Packages (SCPs) -Identified areas of the application under test to perform regression testing and preparing the scenarios for regression testing using in-house automation tool - Participated actively in departmental and cross-departmental meetings - Interacted efficiently with developers and business analysts about product reviews and testing issues - Performed system level risk management for two diagnostic instruments (Fusion and Panther) - Developed submissions documents as per FDA regulations (21 CFR 820) IEC (62304) and ISO (13485) - Assisted with Risk testing as per ISO (14971) - Mentored junior team members, lead projects and reviewed other team members test protocol during validation phase

- Performed smoke, sanity, core regression and feature regression tests on new released builds to find the readiness for further testing. - Performed verification and validation of software applications for medical diagnostics instruments (Panther) - Executed manual and automated test cases using HP Quality Center (QC) in following areas: functional, system, integration, risk mitigation, negative and user acceptance testing - Performed data analysis of stress and regressing test to identify defects in the software.

- Analyzed requirements for diagnostic medical device - Designed risk Analysis documentation(FMEA) for diagnostic medical device - Designed system level reports for FDA submission - Performed hardware and software testing for medical device.

- Processed Applications for new undergraduate and graduate international students. - Assisted students with their application questions. - Performed front desk role such as interacting with students, sending emails, answering phone calls and scheduling appointment with advisors.

- Designed and assembled tube straightness measurement apparatus and procedures. - Developed hardware verification and validation testing for the thermal tube printer for Tomcat. - Analyzed data from the test and made recommendations for design and build modifications.

- Performed smoke, sanity, core regression and feature regression tests on new released builds to find the readiness for further testing. - Reported defects observed during the software testing with detailed analysis and logs - Worked on Diagnostic assays- Aptima Combo, HPV, HPV-GT, TRICH; Bloodbank assays- Ultrio Elite, dHBV, dHCV, dHIV, West Nile Virus.

Product Development Track: Product Development, Software Quality Management, Operations and Entrepreneurship.

Graduated with Honors in Biomedical Engineering, CSU Long Beach. Double Major in Electrical Engineering .