KD&A will take the difficulty out of compiling Technical Documentation for your medical device or IVD
For all medical device and IVD manufacturers, a key component of gaining regulatory approval is technical documentation. This documentation, also known as a Technical File or Design Dossier, incorporates a large amount of product information and can be time consuming and difficult to compile. The documentation describes your device and records how your organisation demonstrates compliance with applicable regulatory requirements.
Technical documentation created by KD&A is developed in line with internationally acknowledged Standard Technical Documentation (STED) guidelines. We provide documentation to meet regulatory requirements for any target market, the following in particular:
- Australia
- EU
KD&A will create a high quality and robust technical documentation for your product(s), ensuring that all necessary criteria are covered. Our experience, once again, helps your company with a smooth journey through this aspect of the regulatory process.
Indicative Fee: between AUD$11,250 and AUD$13,500 plus GST dependant on device type and complexity
Contact us if you require a custom quote.
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