“Form follows function” is also true for your technical documentation: The structure of your product file is not predefined. Merely the content you are to supply as the manufacturer is defined in accordance with country-specific regulations. Different guidelines, however, make it considerably easier to set up the technical documentation
- NB-MED 2.5.1: recommendation of the co-ordination of notified bodies on the minimum content of the technical documentation;
- STED - the summary technical documentation. A standardized format published by the GHTF in 2011 with the aim to create a standard that is accepted for the approval process by many countries.
- Annex II “Technical Documentation” of the proposed ordinance on medical devices by the European Commission dated September 26, 2012.
With affixing the CE marking to your products, you as the manufacturer document consistent conformity with legal regulations. And with our know-how you are always on the safe side.
Contact usOur services in detail
- Providing consulting services regarding the structure and format of the technical documentation,
- Developing the technical documentation in accordance with the requirements of the European directives for medical devices in order to affix the CE marking,
- Developing the technical documentation in STED format,
- Preparing the application documents in accordance with target country requirements.