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The Design History File (DHF) is a key document in the medical device development process. It serves as a comprehensive record that documents the design and development activities of a medical device. The DHF is a critical component of regulatory compliance, as it provides evidence that a medical device has been developed following established quality management systems and regulatory requirements. Here’s a guide on building a Design History File:

Building a comprehensive DHF is not only a regulatory requirement but also a best practice for ensuring the quality and safety of medical devices throughout their lifecycle. A well-maintained DHF facilitates regulatory submissions, audits, and ongoing product development and improvement.