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 …
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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 …
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 …
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 …
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 …
Na poli digitálního zdraví zdravotnické pro- středky typu SaMD shromažďují a analyzují data získaná z různých lékařských snímků, dále data o fyziologických funkcích, laboratorních …