Software as Medical Devices (SaMD) and the impact of the application of AI on Validation
As AI becomes a core element of SaMD, the challenge of validating these technologies while adhering to stringent healthcare regulations becomes paramount. This webinar will address the specific impact of AI on SaMD, validation processes, with expert insights on balancing innovation and compliance.
You will learn and get insights in:
- The regulations you need to adhere when developing software and/AI as a Medical device.
- The elements from the related guidance’s for regulations will drive the level of quality and effectiveness of your products.
- How to implement risk-based validation approach by introducing Computerized System Assurance principles that assures the success of your wholeness of your services in agile development environment.
- Which areas and activities in your product development stages AI can accelerate and optimize your development process.
