Description

The traceability Matrix Template provides a general structure to build the correct link between risk management process and design and development process.

The Traceability matrix is an essential tools in the framework of the design process of medical devices, as per Iso 13485 section 7.3. With its clear instructions and structured format, our template simplifies the process of compiling comprehensive design traceability matrices. Each section guides users methodically through essential components, from succinctly tracing design inputs to documenting design outputs and verification activities.

The traceability matrix is an essential tools for medical device manufacturers to reach an appropriate level of compliance and substantially simplify the risk management process.