Technical File 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 the Technical File for your device that complies with the applicable medical device regulations.

For all medical device and IVD manufacturers, a key component of gaining regulatory certification is the Technical File. 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 Technical File describes your device and records on how your organisation demonstrates compliance with applicable regulatory requirements.

Technical File documentation created by KD&A is developed in line with the latest internationally acknowledged standards, guidelines and common specifications. We provide documentation to meet regulatory requirements for any target market, in particular:

• Australia
• EU

KD&A will create high quality Technical File for your product(s). One that complies with the applicable medical device regulations, standards, industry guidelines and common specifications. Our experience, once again, will help your company with a smooth journey through this aspect of the medical device and IVD regulatory process.

Contact us for a custom quote.

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