Traceability is an essential aspect of medical device development and manufacturing. It involves the ability to trace the history, use, or location of a product from its origin to its final destination. In the medical device industry, traceability is especially important because it helps ensure that devices are safe, effective, and high-quality.
Several medical device standards require traceability between tests and requirements. These standards are in place to ensure that medical devices meet the necessary requirements for safety, performance, and quality.
One such standard is the International Organization for Standardization (ISO) 13485:2016 standard for medical device quality management systems. This standard requires that medical device manufacturers establish and maintain a traceability system. It is to ensure that devices are manufactured and tested in accordance with the requirements specified in the design and development plan. This includes traceability between test results and the requirements to design and develop the device.
Another standard that requires traceability between tests and requirements is the Food and Drug Administration’s (FDA) Quality System Regulation (QSR). This regulation requires medical device manufacturers to establish a traceability system. This traceability mechanism tracks all devices throughout the design, development, production, and distribution process. This includes traceability between test results and the requirements to design and develop the device.
The International Electrotechnical Commission (IEC) 60601-1 standard for medical electrical equipment also requires traceability between tests and requirements. This standard specifies the requirements for the safety of medical electrical equipment and systems, including traceability between test results and the requirements used to design and develop the device.
Orcanos system comes with a complete test management system validated according to the requirements of the above standards. It allows the manufacturer to design the validation and verification protocols and maintain a strong baseline matching the produced DHF file. It also allows a bi-directional traceability mapping from the Design Inputs/Outputs to the Verification/Validation and presenting the results of the test, all in one report completely automatically generated from the system.
In conclusion, traceability between tests and requirements is an important aspect of medical device development and manufacturing. Several medical device standards, including ISO 13485:2016, FDA QSR, and IEC 60601-1, require traceability. This is to ensure that devices meet the necessary requirements for safety, performance, and quality. By maintaining a traceability system, medical device manufacturers can ensure that their devices are safe and effective for use by patients.