Nabil Khan
About Nabil Khan
Biomedical Engineer by training with an emphasis in bioinstrumentation, computational modeling/numerical methods, and human anatomy and physiology. Software Engineer by profession with an exclusive focus on medical devices. Significant experience leading and executing embedded software design and development efforts across a variety of medical device product codes and classifications (Class I/II Devices with IEC 62304 Class A, B, and C Software Systems), the majority of which are new product designs. Major involvement across all phases of software development life cycle, including very proactive roles in risk management activities (DFMEAs, Process FMEAs, Safety Assurance Cases) and development/test/VnV planning activities, with corresponding documentation generation. My design and development experience is primarily focused on Embedded Software Systems implemented in C/C++. Extensive experience from low to high level code development and testing, including low-level drivers, custom GUI frameworks, multiDOF motion control, and other moderate-complexity control systems. Proficient in Several Critical Standards/Guidelines for Medical Device Software Development, including: - IEC 62304:2015 (especially concerning Class B and C Systems) - ISO 14971:2019/24971:2020 - ISO/TIR 80002-1:2009 Application of Risk Management for Medical Software - ISO 13485:2016 - ISO 60601 Collateral and select Particular standards - 21 CRF 820 - FDA Software Related Guidances to Industry (Software Validation, OTS, Cybersecurity, Premarket Submissions etc) I’m very interested in growing/leveraging my skills and experience to develop and commercialize novel technologies to the Medical Device Space. I am a strong believer in structured, methodical problem solving, with a particular focus on approaching design/development challenges in this space from a risk-based perspective.