Life Science Outsourcing has the resources to assist medical device manufacturers with design DHF, including conditions, tasks, and activities.
A well-documented Design History File (DHF) is essential for FDA compliance, quality assurance, and a smooth path to market. As part of our end-to-end solutions, we help medical device manufacturers develop and maintain a DHF that ensures traceability, mitigates risks, and meets regulatory requirements. Partner with LSO to simplify compliance and accelerate your product’s success.
The device design history file is a collection of documents that describe a medical device design and development process in detail to meet U.S. FDA regulations. Documentation spans every aspect of the development process, from concept to production, with the goal being verification of the device’s ability to meet user needs and intended uses.
It is necessary for regulatory compliance, quality assurance, and successful market entry for medical devices in the United States. Without the proper ISO-certified setting, it could be invalidated, costing manufacturers time and revenue.
Device DHF must meet the following:
Regulatory compliance
The FDA requires the DHF as a regulatory requirement to serve as evidence that the design was developed according to established regulations and standards.
Traceability
DHF provides traceability from initial design inputs to the final product, guiding the design to meet all specified requirements.
Risk management
A well-maintained DHF allows manufacturers to document risk management activities, showing that potential risks were identified, assessed, and mitigated throughout the design process.
Quality assurance
A DHF supports quality assurance processes by demonstrating a systematic and documented design approach and reducing the likelihood of design flaws or errors.
A DHF is necessary for design engineers and developers, as they are responsible for creating and maintaining design documentation. Quality assurance and regulatory teams, project managers, and auditors also use the DHF to meet requirements.
The DHF process typically follows several well-established steps. These can include:
A design DHF is a mandatory requirement under FDA regulations for medical device manufacturers. They are required to maintain a DHF to show that the design was developed in accordance with approved design controls. If a DHS is not properly maintained, the results can include regulatory action such as warnings, fines, or even product recalls.
Our medical device incubator services offer comprehensive support for medical device development, including facility utilization, quality management guidance, FDA registration assistance, clinical and R&D builds, full traceability, and product packaging and validation support. Contact us today to get started with your device DHF development project.
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