Last January, the Federal Institute for Drugs and Medical Devices (BfArM) in cooperation with the German Ministry of Health created an office in order to provide regulatory consultancy to startup companies.
Thanks to this Office, the BfArM wants to help innovative biotech startups, research institutes and other organizations without regulatory experiences to avoid missteps during the procedures to market their devices.
By involving this office during the early phase of the design stage, the BfArM should disclose potential problems in time avoiding delays and unnecessary costs to these organizations.
For example, the healthcare mobile apps developers will be able to understand if their software can be classed as Medical Devices. Or, more in general, manufacturers will recognize early if pre-market clinical trials are required.
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