Do Medtechs Know What They Want To Achieve With Digital?
It is the question that continues to exercise the minds of management boards in the medtech industry even as digital health care tools become increasingly ingrained in commercial R&D and operations – and in patient treatment pathways.
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Without the MRA that allows unimpeded bilateral device trade between the EU and Switzerland, Swiss industry is having to find ways of limiting the damage that newly erected barriers will cause after the MDR comes into force.
The Swedish liquid biopsy start-up expects to be the first company to secure US FDA approval for a metabolism-based urine test for the early detection of kidney cancer in post-surgery patients.
Singapore Prepares UDI System, Malaysia Seeks Regulatory Improvements And Indonesia Adjusts To Changing Environment
Medtech industry representatives from ASEANMed member economies, notably Singapore, Malaysia and Indonesia, provided regulatory updates at the February Asia Regulatory Roundtable. These roundtables are organized by the ARQon consultancy and the Asia Regulatory Professional Association (ARPA). They are sponsored by Medtech Insight.