Hima Chetty

Principal Consultant

Hima is an electronics and biomedical engineer with more than 12 years’ experience leading, managing, and delivering compliance projects in the MedTech industry.

Hima’s unique blend of experience comes from working on a multitude of projects within the medical device industry ranging from testing to safety standards, preparing regulatory submissions, helping clients with their global market-access strategies, risk management, usability studies, quality assurance and design and development of Medical Devices (Hardware, Embedded Software and SaMD).

During her time at Intertek and UL Solutions, Hima has worked with a diverse group of clients that included a wide range of medical electrical equipment such as defibrillators, MRIs, Patient monitoring devices, ECG, Ultrasound, Ventilators, Infusion pumps, FES devices, Surgical Robots and Software applications which has enabled Hima to understand and develop the best-suited regulatory pathway to market access. Working at a technical body gained Hima the experience of working with regulatory agencies such as the FDA, EU NB, Health Canada, SCC Canada, TGA etc. In addition, she also has extensive knowledge and understanding of working in ISO 17025 environments, ISO 13485 and US FDA QSR.

At Philips Healthcare, Hima worked within the R&D group, managing and creating requirements, maintaining risk management, V&V activities and Usability studies for Emergency Patient Monitoring Devices and Software Platforms. In addition, she gained experience in MDSAP, MDR audits, MDR and FDA 510K submissions. Hima was awarded the “Patient Safety and Quality Always” award for her contributions to educating teams, maintaining technical documentation, and providing solutions to navigate the regulatory and quality landscape.

Hima is passionate about process improvement and implementing lean principles within an organization. Her strengths include fostering collaborative partnerships with colleagues, understanding regulatory challenges, and working hand-in-hand to develop tailored, effective solutions to maintain a safe product on the market.

In her role as Principal Consultant at Compliance Solutions, Hima provides strategic insights and expert guidance to clients, leveraging her extensive knowledge of the MedTech ecosystem. Hima’s expertise is in Medical Electrical Equipment, SaMD (Software as Medical Device), Clinical Decision Software, and Machine learning algorithms in Medical Device software.

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