MDR and IVDR regulations in Europe and similar moves to tightening compliance across the globe have led to a lot of concern in the medical device industry. New devices need to demonstrate compliance, existing devices need to show compliance and all devices need to demonstrate compliance on an ongoing basis.
The inclusion of aesthetics under the MDR regulation brings a whole new sector under governance.
We all understand that different devices require different levels of evaluation and investigation and the due date for meeting the regulations varies, but the message is clear. If you want to market your medical device in Europe, or continue to market your device in Europe, you need to demonstrate compliance, and the clock is ticking.
If you’ve read this far, you understand the problem, but what of the solution? At CRFweb we help people tackle this in a number of ways. If you are underway with the process but need to fast track your study, we can put a study together in a matter of days. The CRFweb EDC system provides all the features you will need for your medical device study in a simple to use compliant package with a comprehensive reporting suite. Read more here .
CRFweb can help you speed up the trial process and meet your compliance deadlines. With integrated ePRO and eDIARY you can configure subject-led responses, which is especially useful for post market evaluations. CRFweb is proven in the market place and currently used by medical device companies across Europe to meet their compliance requirements. We work with Medical Device Organisations directly or with your CRO.