This Medical Software Engineering Template consolidates the medical device software design and engineering process, ensuring compliance, efficiency, and quality.
Our Medical Software Engineering Template specifically helps in the adoption of best practices for medical device software engineering with minimal effort. It greatly reduces the time and effort needed to develop quality digital health products that comply with EU MDR, U.S. FDA regulations, and other international standards. Use this template to effectively manage medical device software design and engineering processes from requirements to validation and regulatory audits.
This template is also an extension to Codebeamer, offering instant access right out of the box to best practices, regulatory compliant processes, and health tech domain knowledge. It provides predefined assets and workflows for medical device development and compliance. Time and effort are saved in configuring Codebeamer to ensure compliance and reduce risks in developing complex health technology products.