Your product ‐ correctly and fully documented
By means of legal provisions and the increasing number of directives and standards, it is becoming more and more difficult for manufacturers to comply with all requirements. We review and prepare technical documentation in accordance with the legal and regulatory provisions that apply to the documentation of your product.
- Technical documentation encompasses all documents that describe a technical product.
(e.g., technical specifications, design documentation, risk assessments, test reports, applicable standards, operating instructions, EC declaration of conformity)
- The technical documentation ensures the proper use of a product in all stages of its life.
- The technical documentation is divided into internal documentation (documents that remain with the manufacturer) and external documentation (documentation that is provided to the operating company/client along with the product).
- The technical documentation must be prepared according to applicable legal provisions (directives and standards). (e.g., DIN EN 82079‐1 | machinery directive| low voltage directive | EMC | ATEX | EN ISO 12100 | EN ISO 13849‐1 | EN ISO 13485)
- In the event of damage, the technical documentation guarantees that your product was placed on the market free of faults.
- The technical documentation must be available before the product can be offered for sale.
- The technical documentation must be submitted within a reasonable timeframe to the responsible market surveillance authority.
- The technical documentation must be stored for at least ten years.