- Missing or fragmented documentation
Incomplete or unstructured Medical Devices Technical Files can lead to approval delays or outright rejections. - Unclear expectations from regulators
MDR Technical File requirements — along with those from TGA and Medsafe — vary in structure, terminology, and depth. - Limited internal resources
Regulatory teams are often stretched thin and struggle to keep documentation current and compliant. - No clear starting point
Especially for startups or new markets, building a compliant technical file for medical devices can feel overwhelming.
MDR Documentation that aligns with MDR, UKCA, and local authority expectations
In MedTech, accurate and structured documentation is key to certification. From general safety and performance requirements (GSPRs) to clinical evaluation and risk management, every part of your technical file must stand up to regulatory scrutiny.
We help you create and maintain complete, audit-ready technical documentation for medical devices – whether you’re preparing for UKCA, TGA, or Medsafe approval.
We help you create and maintain complete, audit-ready technical documentation for medical devices – whether you’re preparing for UKCA, TGA, or Medsafe approval.
Your Challenges
How We Help
- Structured Technical File Creation
We help you compile all required elements for your MDR Technical File – from device description to risk management and GSPR checklists. - Document Review & Gap Analysis
We evaluate your existing medical devices documentation, identify gaps, and highlight what needs to be added, adjusted, or corrected for certification. - Localised Templates & Guidance
You get document structures tailored to UKCA, TGA, and Medsafe expectations – ensuring your technical file aligns with local and international requirements. - Compliance for Certification
We prepare your Medical Devices Technical File and related documents for regulator or notified body review – complete, consistent, and audit-ready.
What Our MDR Technical Documentation Support Covers
MDR Technical File Assembly
Build complete documentation in line with MDR, UKCA, TGA, or Medsafe requirements.
GSPR Mapping & ISO 13485 Alignment
Link each requirement to evidence and ensure quality system alignment.
Clinical Evaluation & Risk Management
Create audit-ready documents based on the latest guidance and best practices.
Ongoing Documentation Maintenance
We help you manage updates for design changes, PMS/PMCF, or regulator feedback.
Submission-Ready Formatting
Ensure your files are clean, structured, and ready for upload or physical submission.
Collaboration with QA/RA Teams
We integrate seamlessly with your team or external consultants – no micromanagement needed.
