SaMD (Software as a Medical Device) Training
Explore SaMD development, regulatory standards like IEC 62304, and strategies to ensure compliance in medical device software.
Overview
Software as a Medical Device (SaMD) refers to software intended for one or more medical purposes that performs these purposes independently of any hardware medical device. As defined by the International Medical Device Regulators Forum (IMDRF), SaMD is becoming increasingly vital in healthcare, enabling innovative solutions for diagnosis, treatment, and patient management. Our SaMD Training provides an in-depth exploration of regulatory requirements for medical device software, emphasising essential standards such as IEC 62304, ISO 14971, IEC 62366, and IEC 81001-5-1. The course addresses important compliance practices, helping participants effectively integrate regulatory standards into their SaMD development processes.
Benefits of Attending
- Acquire detailed knowledge of critical regulatory standards for SaMD, including IEC 62304, ISO 14971, IEC 62366, and IEC 81001-5-1. Understand how to apply these standards effectively in the development and maintenance of compliant medical device software.
- Learn about the regulatory frameworks that govern SaMD, including risk categorisation and quality management systems.
- Gain insights into practical examples of SaMD applications in healthcare and the implications for product development.
- Understand the differences between SaMD and other software types, such as Software in a Medical Device (SiMD).
- Develop strategies for ensuring compliance with evolving regulations and best practices in SaMD development.
Who Should Attend?
This training is designed for:
- Regulatory affairs professionals working with software products in the medical device industry.
- Quality assurance specialists responsible for ensuring compliance with medical device regulations.
- Software developers and engineers involved in creating SaMD solutions.
- Healthcare professionals interested in understanding the implications of SaMD on clinical practice.
- Business leaders seeking to align their organisations with current regulatory standards in digital health.
Comprehensive, Expert-Led Training Hub
Gain industry-leading insights with structured, interactive courses designed to simplify regulations, enhance compliance, and drive industry best practices.
