“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.
Our 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.