Technical Documentation for Medical Devices and In Vitro Diagnostic Medical Devices
No CE-Marking without Technical Documentation!
"Well established devices in the market do not need any further documentation." This opinion and nearly similar comments on only small documentation tasks for "Grandfather Products" are well known in the market.
Unfortunately it is not possible to find this circumstance in the European Directives or national laws! In the opposite the documents do not even differentiate between new end well established products. All devices with CE-mark need a Technical Product File. However the marketing experience can be used to make the evidence of effectiveness of the chosen measurements in Risk Management more comfortable.
All this papers...
The European legislator did not regulate the way to realize the Technical File. So the classic way to establish a lot of paperwork is equal to a fully electronic documentation system which can be adapted to Your Quality Manual as well. The only requirement is to assure the readability end repeatability of archiving.
consulting & more and its partner companies can realize this documentation system for You even in the fully electronic way.
The language of the Documentation
The Technical Product File of a German manufacturers product must be held in German language? This definition does not exist! The manufacturer is only forced to use a language of the European Union. For the Instructions for Use is for example in Germany a document in German language needed. But every national law hag the possibility to define the needed language in an individual way.
If You have questions about the contents, layout and languages of the Technical File or the IfU consulting & more will support and will analyze the needed national requirements.
Whose job is the Documentation?
According to the standards the documentation task is to be realized parallel to the product development. This procedure uses a lot of synergies and creates a minimum of work and expenses.
In reality the most devices are ready for market introduction when the documentation task is started. In many Gases the product Is not even developed by the manufacturer itself. Under these circumstances documentation can become a great task for a detective!
You don't really like documentation work? You do not have the time to take all these papers again in Your hands? You are searching for the perfect way combining all the needs of the European Directives (MDD, IvDD), 510(k) or PMA and Quality Management? consulting & more would be pleased to help.
Even a fully electronic documentation system can be realized by consulting & more and its partner companies. We organize the whole service for You!
