Preparing technical documentation for the TGA or EU MDR is complex and time consuming, particularly while requirements continue to evolve. Errors and gaps lead to delays, non-conformities, and in some cases rejection.
Compliance Management Solutions provides end to end support to make sure your technical file is complete, compliant and audit ready, and can equip your team to maintain it afterwards.
Technical documentation preparation
We develop regulator ready technical files tailored to your device and target markets, covering:
- Device description and specification
- Intended purpose, indications and contraindications
- Risk management documentation aligned to ISO 14971
- Clinical evaluation and performance evaluation support
- Biocompatibility and pre-clinical evidence planning
- Usability engineering documentation
- Labelling, IFU, and GSPR or Essential Principles compliance
- Post-market surveillance and vigilance planning
Our approach aligns with TGA requirements, EU MDR 2017/745 requirements, and the relevant international standards and guidance documents.
One day practical training
We also run a one day session for regulatory, QA and product teams who want to prepare and maintain technical documentation internally. It covers the structure and content of a compliant technical file, the key differences between TGA and MDR expectations, how to interpret and apply the GSPRs and Essential Principles, the gaps that commonly appear in audit findings, and how to keep documentation current as the product changes.
Whether you would prefer we handle the documentation or train your team to do it, please contact our regulatory team to discuss what suits you.