EU MDR and FDA’s Case for Quality are just two of the initiatives impacting medical devices in 2019. According to the new EU MDR (European Union Medical Device Regulation), combination products must meet medical device standards. This is new. Listen to Steve’s advice on where to get more information.
Also: How do you go from managing projects in dirty chemical plants to Healthcare IT projects to Medical Devices and back to Pharma? What is the difference between medical devices and pharmaceuticals? What are FDA and European Union medical device regulators doing in 2019 that Medical Device and Pharma professionals need to know about?
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