Ensure Compliance & Peace of Mind with Expert Design History File Management
Sunrise Labs simplifies DHF creation, maintenance, and submission, empowering you to focus on innovation
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.
Strength through strategy
and transformation
Creating a robust Design History File (DHF) is critical to regulatory compliance and product success. Sunrise Labs provides expertise to ensure your DHF is comprehensive, well-organized, and audit-ready.
