Standards, Laws & Guidelines.

Standards, laws and guidelines form the legal framework for the technical documentation of your products. That is why it is important that you know these requirements and apply them consistently.

Wir erstellen für Sie rechtskonforme Technische Dokumentation.

Legally compliant technical documentation.

Do you know all the legal requirements of the technical documentation of your products?
Do you know whether your technical documentation meets all legal requirements?

If you cannot answer these two questions with an unequivocal yes, then we will be happy to advise you on the subject of standards, laws and guidelines in technical documentation.

We can review your documents for you and compile any necessary changes. We can also revise your documents for you to ensure all requirements are promptly met.

The basics.

The legal basis for technical documentation in Germany is formed by three laws:

Product Safety Act (ProdSG)
Product Liability Act (ProdHaftG)
Civil Code (BGB)

Wir beraten Sie rund um die Themen Normen, Gesetze und Richtlinien für Ihre Technische Dokumentation, Bedienungsanleitung und Gebrauchsanweisung.

Die Maschinenrichtlinie wird zur Maschinenverordnung. Wir beraten Sie zu den Änderungen für Ihre Bedienungsanleitung.

Regulations and guidelines.

Depending on the products you manufacture or place on the market, you must also comply with various European regulations and directives.

Machinery Directive (2006/42/EC) and the forthcoming Machinery Ordinance
IVDR and MDR for medical technology
2019/882 Accessibility requirements for products and services
Further European regulations and directives

Standards and their implementation.

When creating your technical documentation, you must observe various standards and implement them in a suitable manner. First and foremost, type A standards, which are used as the basic standard in many industries.

IEC/IEEE ‑820791
Drafting of instruction manuals – Structure, content and presentation – Part 1: General principles and detailed requirements
DIN EN ISO 20607:2019-10
Safety of machinery – instruction handbooks – General principles for design
ISO IEC IEE 26514
Systems and software engineering – Design and development of information for users
EN ISO 12100
general design principles
ISO 13485:2016
Medical devices – Quality management systems – Requirements for regulatory purposes
ISO 20417:2021-04
Medical devices – Requirements for information to be provided by the manufacturer

You must also check which technical standards (type B and C) additionally apply to your products. Many technical standards describe requirements for technical documentation that must also be observed.

Die Norm 82079 ist eine der Normen für Technische Dokumentation und Ihre Bedienungsanleitung.

Unsere Checklisten zum Erfüllen der Anforderungen der Norm 60601

Our checklists for your technical documentation.

We are happy to help you on your way through the jungle of laws, standards, guidelines and regulations to legally compliant technical documentation. Our checklists on laws, standards and guidelines for technical documentation are a proven tool for managing requirements.

We can review your technical documentation for you, identifying gaps and pointing out the superfluous, so that in the future you comply precisely with what the legislator requires.

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