A Design History File (DHF) ensures that the design and development of all medical products are safe, effective and meets the intended end user needs. The DHF is a set of documents or records used for demonstrating that the products are designed and developed in accordance with Good Manufacturing Practice (GMP) requirements and that the design control requirements are as per regulations. As per 21CFR Part 820 Subpart - Design Control, Sec 820.30, each manufacturer of any class III or class II device, and even the class I devices, shall establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met.
DHF remediation is a process of making all the Design Control/DHF elements to be compliant with the regulation 21 CFR Part 820, and the global international standard ISO 13485:2003/ISO 13485:2016. Design Verification is one of the prime/important element in the DHF.
Design Verification means establishing the objective evidence that specifications (specified requirements) conform with design input requirements. Inspection, Testing and Verification are performed to prove that final finished product can be used by end users with their expected use conditions.
This White Paper focuses on the approach to be followed to find the gaps (available/missing) in verification documents of legacy products during the DHF remediation and the remediation approach to be followed to fulfill the gaps.