Technical Documentation
Comprehensive regulatory documentation for MD & IVD
The new regulations for IVDs and medical devices introduce more stringent requirements for technical documentation and clinical evidence. With over two decades of experience, we offer unparalleled expertise.
What is technical documentation?
The new regulations for IVDs and medical devices introduce more stringent requirements for technical documentation and clinical evidence. With over two decades of experience, we offer unparalleled expertise.
We handle your medical writing tasks and provide answers to your regulatory questions with precision and professionalism. Our experts stay on top of the evolving regulatory landscape so you can focus on what you do best.
Why partner with QbD Group?
Tailor made solutions — We provide bespoke technical documentation services that align with your specific product requirements and regulatory pathway.
Technical file compilation
Complete compilation or review of your technical documentation for MDR/IVDR compliance.
Clinical evaluation
Clinical evaluation reports, literature reviews, and equivalence assessments.
Risk management
Comprehensive risk management documentation aligned with ISO 14971.
Gap assessment
Thorough gap assessments to identify and address documentation deficiencies.
Why QbD Group
Your trusted partner
When it comes to regulatory requirements for your IVDs and medical devices, our team puts your needs first.
Over 20 years of experience in medical device and IVD technical documentation.
Expertise across all device classifications and regulatory pathways.
Deep understanding of MDR, IVDR, and international regulatory requirements.
Proven track record of successful Notified Body submissions.
Let's talk Regulatory Affairs
From regulatory strategy to product approval, our experts are ready to guide you through every step.