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.
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)
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.
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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Take advantage of our no-obligation initial consultation.