Medical Devices Speaker Series 2023: Achieving IEC 62304 Certification for Neuromodulation Devices

Developing neuromodulation devices that interface with the nervous system presents unique challenges, especially when it comes to achieving IEC 62304 certification. This presentation by Adarsh Jayakumar from Boston Scientific, explores how MathWorks tools can help you navigate the complexities of the standard and accelerate your path to compliance.

Discover how MathWorks solutions can support your neuromodulation device development by:

• Optimizing software development lifecycle processes: Implement efficient and compliant processes tailored to IEC 62304 requirements.
• Facilitating risk management: Identify, analyze, and mitigate risks associated with your device software using industry-standard methodologies.
• Simplifying verification and validation: Leverage powerful tools for comprehensive testing and documentation to ensure software quality and compliance.
• Streamlining documentation and evidence generation: Generate the necessary documentation to demonstrate compliance with IEC 62304 efficiently and effectively.

This presentation was given at the 2023 MathWorks Medical Devices Speaker Series, which is a forum for researchers and industry practitioners using MATLAB^® and Simulink^® to showcase and discuss their state-of-the-art innovations in the areas of medical device research, prototyping, and compliance with FDA/MDR regulations for device certification.

About the presenter:

Adarsh Jayakumar is a manager of embedded systems in the neuromodulation division at Boston Scientific. His current focus is on scoping and mitigating the technical risk of embedded software projects such as IEC 62304 certification of Class-II and Class-III medical device software. Adarsh received his master’s degree from Cornell University, and his graduate work focused on designing a novel technical tool to study cardiac neurophysiology.