FDA-Submissions for Medical Devices and In Vitro Diagnostic Medical Devices


Even for the European manufacturers the limitation on only the European market is to risky to get Return of Investment for innovative medical devices. In this days the expenses for developing a medical device are much to high to concentrate on only one single market. But the US market makes it necessary to get all the Medical Devices and IvD Medical Devices FDA approved. It is a task to combine the European CE-mark and FDA-Approval but it generates the possibility of getting access to other markets as well.


510(k) or PMA?

Before starting the approval process the manufacturer should make sure which procedure is needed to be chosen. All tasks as time frames, expenses etc. are based on the decission of the approval procedure. consulting & more will assist You by doing a research on predicate devices and by creating a documentation system and rational for "Substantial Equivalence" (SE) for the filing process. Again consulting & more will assist You in the same way to realize and give rational for product classification.

Risk Management and Technical File

Like in the European Union the manufacturer is forced to create and hold a product documentation for each medical device and IvD medical device. consulting & more will support You in changing Your CE product documentation into a current FDA required Technical File. On demand consulting & more will also show You the way to a complete documentation system fulfilling all the requirements of MDD or IvDD, national Regulations and the US requirements.

Quality Management, QSR and Design Control

The needed documentation is not only focussing on the product features, also the device design, testing and manufacturing processes are to be described. In the end the assignment is to combine the processes demanded by ISO 9001 and ISO 13485 with the requirements out of QSR, Design Control, Guideline and Guidance documents and IEEE standards including Risk Management.

consulting & more would be proud to share its longtime experience in realizing the above tasks. Take the chance to save time and expense! consulting & more will get You testing laboratories or a partner in the Mutural Recognition Agreement if it is useful.

Together we will shorten the time to market clearance! Test it!