Description

The Design Review Template is a structured document used in accordance with ISO 13485, an international standard for quality management systems in the medical device industry. This template serves as a systematic tool for evaluating the design and development process of medical devices at critical stages throughout the product lifecycle. It outlines specific criteria and requirements that must be assessed during design reviews, such as design inputs, risk management, verification and validation activities, and regulatory compliance. By utilizing the Design Review Template, medical device manufacturers can ensure that all necessary aspects of the design process are thoroughly evaluated, documented, and controlled. Compliance with ISO 13485 and adherence to the Design Review Template help to mitigate risks, enhance product quality, and ultimately contribute to the safety and efficacy of medical devices.