“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.
Facing challenges with a smile
True, the requirements for you as a manufacturer are enormous: The EU agrees on a new medical device regulation (MDR) in nearly no time and leaves manufacturers with an interim period of no more than three years to lift all medical devices to MDR level. MEDDEV 2.7/1 revision 4 increases the planning pressure on manufacturers: The notified bodies call for updated clinical evaluation already. And the ideas for software as a medical device often seem to be well ahead of its documentation. Knowing that there is a partner at your side with comprehensive know-how and many years of experience with the documentation and approval of medical devices and IVDs along with their verification and validation, there is no need to worry. We are committed consultants and service providers. Together we make your project a success.We look forward to getting to know you!