The EU Medical Device Regulation (EU MDR 2017/745) poses numerous challenges for medical device manufacturers of all classes. This also affects clinical data capture after medical devices have been placed on the market. With the new regulation, manufacturers must prove that their products are delivering in terms of safety and performance throughout their lifecycle. If these demands are not met, products could be taken off the market and/or lose their certification.
To avoid such scenarios, an electronic data capture (EDC) solution is indispensable nowadays. EDC ensures the efficient collection, management and evaluation of high-quality data to prove that products are delivering on their promised benefits. 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 (Figure 1 – multiple choice question).
In this Whitepaper, we highlight the typical hypotheses that prevent manufacturers from switching to electronic solutions for their data capture. We also explain which advantages EDC solutions actually offer in practice according to our experience.
Some of the most common assumptions around EDC include:
For each hypothesis, we offer some counter examples. So don't take our word for it, take a look at the examples and statistics!
About Climedo Health
Climedo Health’s mission is to bring the best treatment to every patient by empowering healthcare professionals with intelligent software solutions. Together with Europe’s leading hospitals, we have developed a cloud-based platform for cutting-edge clinical validation and post-market surveillance of medical devices and pharmaceutical products.
By digitally connecting all stakeholders (Medical Device manufacturers, Pharma companies, CROs, hospitals and patients), Climedo allows for increased performance, better cost-efficiencies - and ultimately - accelerated medical innovation.
Learn more: www.climedo.com.