FDA-rules could stand in the way of app-development
When app-developers, in-experienced in the medical equipment-business, undertake the development of medical apps, they could fall victim to FDA-rules about the approval of medical equipment.
af KRESTEN MORTEN MUNKSGAARD
When a Danish software company some time ago presented its newest medical-app for smartphones to CEO of sales and innovation in Scion DTU, Martin Stenfeldt, he asked the company what considerations they had made concerning a 510k-approval. The answer was stunned silence.
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