Preparing Technical Documentation for TGA or MDR can be complex, time-consuming, and overwhelming — especially when requirements are constantly evolving. Errors or gaps can lead to delays, non-conformities, or even rejection.
At CMS SciDoc, we provide end-to-end support to ensure your Technical File is complete, compliant, and audit-ready — while also equipping your team with the knowledge to maintain it confidently.
🔹 Technical Documentation Preparation
We develop high-quality, regulator-ready Technical Files tailored to your device and target market requirements, including:
• Device description and specification
• Intended purpose, indications & contraindications
• Risk management documentation (ISO 14971 aligned)
• Clinical evaluation / performance evaluation support
• Biocompatibility and pre-clinical evidence planning
• Usability engineering documentation
• Labeling, IFU, and GSPR/Essential Principles compliance
• Post-market surveillance and vigilance planning
Our approach ensures alignment with:
✔ TGA (Australia) requirements
✔ EU MDR 2017/745 requirements
✔ Relevant international standards and guidance documents
🎓 One-Day Practical Training – Build Your Internal Capability
We also offer a comprehensive one-day training session designed for regulatory, QA, and product teams who want to confidently prepare and maintain Technical Documentation in-house.
In this session, you will learn:
• Structure and content of a compliant Technical File
• Key differences between TGA and MDR expectations
• How to interpret and apply GSPR/Essential Principles
• Common gaps, audit findings, and how to avoid them
• Practical tips for maintaining documentation lifecycle and updates
Whether you want us to handle your documentation or train your team to do it internally, CMS SciDoc provides a practical, compliant, and efficient solution.
📩 Get in touch today to discuss your needs: info@cmsscidoc.com