Description

The Design & Development Plan Template is a crucial tool utilized in conformity with ISO 13485, an international standard for quality management systems in the medical device industry. This template serves as a structured framework for outlining the processes and activities involved in the design and development of medical devices. It provides a roadmap for managing key aspects such as design inputs, outputs, reviews, verifications, validations, and risk management throughout the product development lifecycle. By using the Design & Development Plan Template, medical device manufacturers can ensure that all necessary steps are documented, controlled, and executed systematically to meet regulatory requirements and achieve product quality objectives. Compliance with ISO 13485 and adherence to the Design & Development Plan Template help to mitigate risks, enhance product performance, and ultimately contribute to the safety and efficacy of medical devices.