Chapter Literature Review – Digital Maturity assessment for medical device company Prepare a literature review starting from overall Digital Maturity assessment models and streamline on Digital Maturity assessment for Medical device companies.
With the adoption of EU MDR, can you think of 3 widely used medical device products that may require much higher scrutiny vs. the historical CE mark route?
EU CE Mark and MDR Historically, getting a CE mark and bringing a product to market in the EU was seen as straightforward, predictable, and the preferred geography to launch a product initially. Does the MDR change this perception? Why or why not? You may want to consider the U.S. FDA framework and trends in […]