Medical Writing with Clinical Research by Deloitte
SaMD is subject to the same general clinical evaluation principles as other medical devices (MDR). The MDCG 2020-1 guidance document specifies that the content of the clinical evaluation of an SaMD …
Inorganic growth activity in life sciences—are we in the eye of the storm? With record levels of capital available across life sciences players1 and a record year of dealmaking behind us, the outlook for …
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The next wave of innovation - Deloitte
Nov 29, 2018 · Keeping pace with technological advances at the FDA Over the last five years, the US Food and Drug Administration (FDA) has clarified its regulatory approach for new and innovative …
Medtech R&D spend is estimated at US$39 billion by 2024. Software-as-a-Medical Device (SaMD) is a rapidly growing area of innovation that regulators across the globe are working to de-risk and make …
而因應數位健康產品的發展,美國FDA亦規畫了「數位健康創新計畫(Digital Health Innovation Plan)」與「數位健康產品開發商預認證試行方案(Pre-Certification for Software Pilot Program )」,改善軟體醫 …
The mHealth market heats up and competition increases mHealth is the utilization of mobile technologies (e.g., smartphones, sensors, networks, analytics tools) to provide health care–related …
Na poli digitálního zdraví zdravotnické pro- středky typu SaMD shromažďují a analyzují data získaná z různých lékařských snímků, dále data o fyziologických funkcích, laboratorních výsledcích a jiná data, …