Creating a compliant and audit-ready Design History File (DHF) is essential for medical device approval. Rook Quality Systems ensures your DHF and Technical Files (TF) meet FDA, EU MDR, and ISO 13485 requirements, whether for hardware, software, or AI-driven devices. Our experts provide gap assessments, documentation support, and regulatory alignment, streamlining the process so you can focus on product development while we handle compliance.

Design and Development File

• Design File / Technical File Creation 
• Medical Device File Creation 
• Risk Management File Creation 
• Design Changes Documentation
• Design Transfer 
• Design Record Gap Assessment 
• Design V&V – ISO 10993/11135/14971, IEC 60601/62366

The Value of RookQS DHF/TF Support

• Technical Documentation Expertise – Our expert medical device consultants work with all classes and types of medical devices, regularly preparing product-specific technical documentation, including design inputs/outputs, risk management, and verification and validation activities.
• Comprehensive Gap Assessments – Our team of quality engineers have extensive experience in identifying and addressing documentation gaps, reducing compliance risks resulting in the streamlining of regulatory submissions.
• Audit-Ready Documentation – With a dozen Certified Auditors on our team, we can confidently ensure your MDF and Technical File meet FDA, EU MDR, and ISO 13485 requirements for a seamless approval process.