Traceability Matrix in Medical Device Development | Scilife

Keeping track of medical devices is paramount to ensure the safety of patients. Traceability allows manufacturers to identify, trace, and control medical devices and is necessary for several reasons, chief among them regulatory compliance. Regulatory bodies such as the Food and Drug Administration in the United States and the European Medicines Agency (EMA) in the European Union mandate strict regulations for medical devices. Traceability ensures that devices meet these regulatory requirements,.