Technical Documentation: What is it all about?

Technical Documentation is a vital component of gaining regulatory certification for all medical devices, including in vitro diagnostic devices (IVDDs).  Technical Documentation often called a Technical File, Design Dossier, or STED (Summary Technical Documentation) describes a device,  including the intended purpose, history, design, manufacture and validation.  Manufacturer’s use Technical Documentation to confirm that their device is safe and effective in carrying out its intended purpose, and conforms to regulatory requirements.

Technical Documentation is generally developed in line with the internationally acknowledged Standard Technical Documentation (STED) guidelines created by the Global Harmonisation Task Force (GHTF – now replaced by the International Medical Device Regulators Forum (IMDRF)). Key components of Technical Documentation are as follows:

• Regulatory documents such as the Essential Principles and Essential Requirements, and Declarations of Conformity.
• Design and manufacturing information.
• Validation documents such as physical test reports.
• Clinical evaluation.

Importantly, Technical Documentation must be well organised and current, and therefore should be reviewed when changes are made to the product or related processes. KD&A suggest that a mechanism is implemented within your organisation’s quality management system (if applicable) to periodically review Technical Documentation.

As Technical Documentation is such an important and time consuming part of gaining regulatory certification, it can be wise to involve an expert. KD&A have many years of experience generating Technical Documentation for a large variety of medical devices from low to high risk. We provide documentation to meet regulatory requirements for any target market, the following in particular:

• Australia.
• EU.

KD&A can work with you to create high quality and robust Technical Documentation for your device(s), ensuring that all necessary criteria are covered. Our experience, once again, helps your organisation to have a smooth journey through this aspect of the regulatory process.  Contact us for a personalised quotation.