Technical Documentation

Technical documentation is a requirement for all medical device and IVD products – KD&A, as an expert medical device consultant, can assist you with the development of technical documentation for your device that complies with the applicable medical device regulations.

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 high quality technical documentation for your product(s). One that complies with the applicable medical device regulations and industry guidelines. Our experience, once again, will help your company with a smooth journey through this aspect of the medical device and IVD 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.

 

Have a few questions? Visit our Frequently Asked Questions page.

Let KD&A help you with the development of Technical Documentation that complies with the medical device regulations