4 Units
In Vitro Diagnostic Medical Devices (IVDs) are a key component of healthcare, and pivotal to advancing technology solutions for patient centric care, such as precision medicine and companion diagnostics. This course covers an overview of the technical documentation and available international standards for IVDs, providing a fundamental understanding of the principles behind effective regulation of IVDs.
This course provides a foundation of the regulatory principles governing IVDs and their use in precision medicine alongside companion diagnostics. It also provides an introduction to standards and guidelines playing a pivotal role in meeting requirements to ensure product safety, quality and performance.