Welcome to our course on Software as a Medical Device (SaMD) - Quality Systems and Regulatory Compliance! In this course, we will dive into the fascinating world of software that is designed to be used for medical purposes. SaMD is becoming increasingly prevalent in modern healthcare, offering innovative solutions for diagnosis, treatment, and monitoring of various medical conditions. Throughout this course, we will explore the key concepts, regulations, and quality systems that govern the development and maintenance of SaMD. By the end of this course, you will have a comprehensive understanding of how to ensure the quality and regulatory compliance of SaMD products.

During our lessons, we will cover essential topics such as the regulatory landscape for SaMD, including key guidelines from regulatory bodies like the FDA, EU MDR, and other global regulators. We will discuss quality management systems (QMS) specific to SaMD, highlighting the importance of risk management, software validation, and post-market surveillance. By examining real-world case studies and examples, you will gain practical insights into the challenges and best practices for ensuring compliance with regulatory requirements while maintaining product quality and safety.

Whether you are a software developer, regulatory affairs professional, quality assurance specialist, or healthcare practitioner, this course will provide you with valuable knowledge and skills to navigate the complex world of SaMD. By the end of our journey together, you will feel confident in your ability to develop, maintain, and market SaMD products that meet regulatory standards and deliver safe and effective solutions for patients around the world. Let's embark on this educational adventure together and unlock the potential of software in improving healthcare outcomes!