Agile can greatly support regulated medical device development with the right implementation.
Agile methodology emphasizes iterative development and quick delivery of working software, while regulatory requirements demand a thorough and documented approach to ensure the safety and efficacy of medical devices. Medtech companies are tasked with reconciling these conflicting approaches.
Dr. Andreas Birk, a renowned process expert and founder of Software.Process.Management, recognizes the potential benefits of Agile in medtech development and proposes a gradual path to understand how Agile principles of can be aligned with regulatory constraints. This involves identifying areas where Agile can be adapted to meet regulatory requirements, such as incorporating quality management systems (QMS) into the Agile process.
Agile testing strategies play a vital role in supporting built-in quality and compliance. Medtech companies can integrate testing activities throughout the development process and ensure that their products meet regulatory standards, while maintaining the flexibility and responsiveness of Agile.
Agile practices can align with medtech regulatory constraints to ensure compliance and the delivery of safe and effective medical devices.
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