Streamline the process of creating and updating design information using design controls, ensuring your device maintains and complies with industry standards. See our FAQ below for what a DHF should include.
Documentation developed by an ISO13485 registered quality system defining a strong design control process provides a stress-free pathway to FDA and Global clearance for your device.
Ensure regulatory compliance through comprehensive assessments of your device DHF. This will include proper documentation detailing the device design, development process, every design control step and demonstrating accordance with an approved design plan and product requirements.
Contact us today to schedule a consultation and discover how our DHF Remediation services can complete your product development road to regulatory clearance.
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Leverage our proprietary platform architecture and reduce development timelines by up to 60%.
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The Quality System (QS) Regulation includes regulation on design controls, which detail FDA’s required activities for medical device design and development. Design control regulations provide specific details on how FDA expects manufacturers to implement Quality by Design (QbD) during the product’s lifecycle design phase. Design control is an iterative process following a structured methodology to ensure the device underdevelopment will be safe, effective, and meet end-user needs. Design Control activities must be documented and recorded in a design history file (DHF).
DHF Remediation is crucial for maintaining compliance with regulatory regulations and product requirements and ensuring the safety and effectiveness of medical devices. It helps identify and address any gaps or discrepancies in the DHF, reducing the risk of non-compliance issues during regulatory inspections and product audits.
DHF Remediation typically involves activities such as performing gap analyses, identifying and addressing design-related issues, and ensuring alignment with regulatory requirements. It may also include documentation review, risk assessment, and verification and validation activities.
A device DHF should include the following at minimum:
The duration of DHF Remediation can vary depending on the complexity of the medical device, the extent of the remediation required, and regulatory timelines. A thorough assessment and remediation process may take several weeks to months to complete, depending on the specific requirements.
Medical device manufacturers, including startups, small businesses, and established companies, can benefit from DHF Remediation services. It is especially valuable for companies seeking to ensure compliance with regulatory standards, improve product quality, and mitigate risks associated with non-compliance issues.
To get started with DHF Remediation, you can contact a reputable medical device consulting firm or service provider that specializes in regulatory compliance and quality management. They can assess your specific needs, provide guidance on the remediation process, and help you develop a customized plan to achieve compliance with regulatory requirements.