![]() ![]() Yet, according to our EU MDR survey on the true costs of the new regulation, 69% of manufacturers still use Excel spreadsheets and 47% even use paper for their clinical data capture. EDC ensures the efficient collection, management and evaluation of high-quality data to prove that products are delivering on their promised benefits. To avoid such scenarios, an electronic data capture (EDC) solution is indispensable nowadays. If these demands are not met, products could be taken off the market and/or lose their certification. With the new regulation, manufacturers must prove that their products are delivering in terms of safety and performance throughout their lifecycle. This also affects clinical data capture after medical devices have been placed on the market. ![]() The EU Medical Device Regulation (EU MDR 2017/745) poses numerous challenges for medical device manufacturers of all classes. ![]()
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