ZebraSci can guide clients with an adequate Design Control process to assist with compliance regulations and support Design History File (DHF) management.

DHF serves as a comprehensive record of the design and development activities for combination products. It plays a critical role in demonstrating the safety, efficacy, and quality of your products to regulatory authorities. A well-maintained DHF ensures that all design activities, including risk management, verification, and validation, are appropriately documented and that the product meets the necessary safety/risk and performance criteria. Additionally, a comprehensive DHF provides a foundation for effective post-market surveillance, product updates, and lifecycle management, enabling you to make informed decisions regarding product enhancements, design changes, and risk mitigation strategies.

Prior to starting product development and DHF, companies shall develop a robust internal design control process. Design controls refer to actions taken by pharma and biotech companies to control the design and development of a drug-device combination product. Under an adequate design control process, all steps taken with the combination product development shall be completed in accordance with the requirements outlined in FDA’s 21 CFR Part 820 & Part 4 regulations, and ISO 13485 standards regarding design controls. For that reason, companies shall develop comprehensive procedures that guide the associates on how to follow design controls adequately and how to document internal decision-making throughout the development process of a combination product.

If you need more information, contact us