Kiran Kumar Prabu

About Kiran Kumar Prabu

I bridge AI innovation and medical device regulation for manufacturers. So compliance strengthens the product instead of blocking it.Mission: Educate and support manufacturers to place compliant product on the marketsAI Governance.Regulatory Intelligence- Strategy -Quality management System-Product Development-Risk Management-Regulatory Submission, Licensing, Registration, Maintenance -Post Market Activity- Technical Documentation, Usability Engineering, Design file, Process ImprovementMedical device regulation: USFDA 510k & PMA, registration and listing, MDD/EUMDR/IVDR-CE, IMDRF, GCC, TGA, HSA, India MDR, WHO PQ and other global regulations.Quality management: ISO13485:2016, MDSAP, FDA cGMP QSR 21CFR, ISO 19011:2018, ISO 20387:2018, GCP, Six Sigma, Lean.Medical device Design: Design file, Design control trace table (DCTT)- Design input (DIR) & output requirement, V&V test plan & result, Technical Analysis, Design QA. Change control, Non-Conformity, Deviation, Customer Complaint, CAPA, Test protocol, Sample size determination Qualification and Validation activity, Quality Key Performance Indicator, Continuous Improvement.Standards: BIS-GOI young professional of various MHD, Harmonization of standards,ISO 14971:2019, IEC 60601-1 compliance, IEC 62304-SDLC and working knowledge of International Standards for medical devices, such as ISO, EN, IEC, ASTM, ANSI and/or AAMI to maintain SOTA.Policy: Startegic planner of framing National and International Medical device policy. Framed Draft - India National Medical Device policy, Uniform code for Medical Device Marketing Practices. Medical device usability aspect: Equipment troubleshooting, maintenance & Quality assurance, safety inspections, the Root Cause Analysis of the equipment’s frequent failures, NABH Audit clearance, Efficient in maintaining equipment with Covid19 (WHO Decontamination & Sterilization of Medical device) protocol and Medical Gas Manifold setup.Preparing for RAC(Devices).

Experience

1. Regulatory Affairs Specialist Ii

   美敦力

   Feb 2025 — Present

   2025 Medtronic Medallion Award

Education

• Stanford University

  Specialization, Artificial Intelligence in Healthcare

• SMK FOMRA INSTITUTE OF TECHNOLOGY

  BE - Bachelor of Engineering, Biomedical Engineering (Medical Device)

• Imperial College London

  Specialization , Digital Healthcare and Regulatory Compliance