Applied Precision Medicine brings together consultancy, implementation, and training to deliver genetic tests into commercial clinical use. Covering the continuum from scientific research to medical use needs a broad set of unique services and skills designed for customers at various stages of this journey.
In most countries the application of genetic tests for patient diagnosis and treatment is considered the use of a medical device. Depending on the country it will be classified as a Class 1, 2 or 3 medical device according to the risk of harm to a patient should the test malfunction in some way. We take you through medical device certification for