Designing compliant and comprehensible presentation

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.


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.


Document Management Software

Get familiar with XERI, the secure and efficient document management solution for your organization. As a powerful and modern DMS solution, XERI is perfectly aligned with the processes of the pharmaceutical industry, biotechnology, medical technology, chemistry, cosmetics and food industry as well as other highly regulated industries.

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Systematic document control

Does your company have to meet high standards? The document management system XERI provides an efficient solution based on highest security, from the electronic signature to the system-wide audit trail. Compliance with normative requirements as well as legal regulations is ensured holistically and documented in a comprehensible manner at all times. With XERI you have the right answers to the auditor's questions about your documentation.

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