RookQS’ team of experienced, certified Quality Engineers will help to create and maintain your device Design History File and/or Technical File to ensure compliant design control, risk management, design transfer, and manufacturing oversight per 21 CFR 820.30.
A DHF/TF is key in demonstrating to the FDA that your medical device was developed in compliance with their regulations, applicable standards, and according to the project’s approved design plan. A well organized DHF/TF creates traceability through the device’s design history that lowers the burden during an audit or inspection. The DHF/TF is useful in the change control process by identifying related requirements and documents that may be affected by a proposed design or process change. Establishing the DHF/TF also preserves design-related information within the business and ensures that accurate and up to date information on the design is passed around to employees.
RookQS can also provide expert guidance regarding how and when to conduct your first hazard analysis. We can walk you through creating both your DHF/TF and your Risk Management File (RMF) in parallel. This idea of risk-based design incorporating risk analysis and risk management is found in many ISO and IEC standards. This approach can be a tool used to reduce the time and costs of repeated design iterations that may be required when risk is assessed late in the design process.
Our custom templates for the Design History File/Technical File and Risk Management File have been through many audits and inspections, and can help your company through every step of the certification process.
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The Final Clinical Decision Support (CDS) Guidance, describes the FDA’s regulatory approach to Clinical Decision Support (CDS) software functions. Suffice it to say that much of the previously designated non-device CDS software might no longer…