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MoFo Life Sciences

Software As A Medical Device In Europe – New Regulatory Regime About To Enter Into Force – (Part 3 Of 6)

MoFo Life Sciences on

Having shed light on the relevance of the intended purpose of a medical device when determining whether software qualifies as medical devices software (“MDSW”) under the new EU Medical Device Regulation 2017/745 (“MDR”) in...more

Ballard Spahr LLP

FDA Issues Guidance on Mobile Medical Devices

Ballard Spahr LLP on

The Food and Drug Administration’s recent guidance on mobile medical applications illustrates the FDA’s growing efforts to combat emerging cybersecurity issues that affect patient safety. The guidance, issued in February...more

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