Technical documentation for medical devices

Technical documentation describes installation, usage, maintenance or repair of technical products. It is required for conformity assessment and thus a prerequisite for the approval of medical devices.

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There is hardly a company today in which technical documentation is not used in some ways. Wherever machines or software are used, there are usually also corresponding instructions or manuals. For the creation of the technical documentation of a product, ideally all technical functional areas of the manufacturer are involved. Areas, such as the development and design departments, quality assurance and purchasing departments for specifications, functional specifications, risk analyses as well as documents of the design and production, proof of QA measures and documents to be integrated from suppliers and sub-manufacturers.

In order to ensure the safety of products, state laws and private-law organizations require technical documentation, provided by manufacturers and installers of technical products.

Legal requirements for technical documentation for medical devices result from the Medical Devices Act. The technical documentation (also called "Technical File") is required in order to be allowed to bring a medical device onto the market and to certify quality management. It is written during development and includes all documents that manufacturers must provide in order to subject their medical devices to a conformity assessment.

STED (Summary Technical Documentation)

The Summary Technical Documentation (STED) is a valuable tool for structuring technical documentation. It was created by the Global Harmonization Task Force (predecessor of the current International Medical Device Regulators Forum). The aim was to create globally harmonized approval applications for medical devices. Currently STED is recognized by the USA, Europe, Canada, Australia and Japan. The STED structures the technical documentation in over 200 chapters and sub-chapters.

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