Medical Device Design History Files & Technical Files

Creating compliant and audit-ready Design and Development Files is essential for medical device marketing authorization. Rook Quality Systems ensures your Design and Development File (DDF) and Technical Documentation meet FDA QMSR (21 CFR Part 820), 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 and Development File (DDF) / Technical Documentation Creation
Medical Device File Creation
Risk Management File Creation
Design Change Documentation
Design Transfer
Design and Development Record Gap Assessment
Design Verification & Validation – ISO 10993 / 11135 / 14971, IEC 60601 / 62366

The Value of RookQS DDF Support

Technical Documentation Expertise – Our expert medical device consultants work with all classes and types of devices, regularly preparing product-specific technical documentation, including design inputs and outputs, risk management documentation, and verification and validation records.
Comprehensive Gap Assessments – Our team of quality engineers has extensive experience identifying and addressing design and development documentation gaps, reducing compliance risk and streamlining regulatory submissions.
Audit-Ready Documentation – With a dozen Certified Auditors on our team, we ensure your Design and Development file and Technical Documentation meet FDA QMSR, EU MDR, and ISO 13485 requirements for a seamless marketing authorization review.