Design history file (DHF)

The DHF serves as a comprehensive record of all design activities and decisions that occur during a medical device’s development. It typically includes user requirements, design inputs, design outputs, verification and validation data and risk assessments. Together, these elements provide clear traceability between user needs, product design and the evidence that supports regulatory compliance.

Maintaining an accurate and well-organized DHF helps manufacturers ensure that their products are safe, effective and compliant with international standards. However, managing this document can be complex – involving multiple contributors, departments and review cycles. Using structured content authoring simplifies the creation and maintenance of DHFs. Each document section can be modularized, version-controlled and reused across submissions, while granular access controls and audit trails ensure accountability and traceability. This approach reduces errors, accelerates review cycles and supports global compliance.

RWS helps life sciences organizations simplify and accelerate the creation of regulated content such as Design History Files. Using Tridion Docs, teams can create structured, compliant documentation that supports full traceability, collaboration and reuse.

Our Human + Technology approach combines intelligent automation with human expertise to ensure every DHF is accurate, compliant and ready for audit. By integrating structured authoring, modular content reuse and translation management, RWS enables manufacturers to deliver high-quality, audit-ready documentation faster – reducing risk and time-to-market.