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The CRFWEB team’s focus and experience in medical device investigations means our eClinical platform provides all the tools you’re likely to need to meet your regulatory requirements. CRFWEB will also provide you with the opportunity to discover new scientific, technical and operational insights derived from your data.
Learn more about the Clindox App Direct Data Capture tool to take adavantage of our ePRO and eDIARY modules for subject-led data entry.
Watch the Clindox App Demo below
We are also well positioned for the move towards decentralised and hybrid trials with a number of Direct Data Capture and subject-led data capture options through the Clindox App.
Click on the thumbnail image to read our Info Sheet – Medical Device Clinical Studies explained.
We all understand the transition to European MDR regulations is increasing the burden of compliance for the medical device industry in both gaining and retaining that all-important CE-Mark. Not only will many companies no longer be able base their initial submissions on equivalence, MDR will increase the requirement for Post-Market Clinical Follow-up for most device classes. Naturally, the cost of market access will increase significantly and so there has never been a better time to develop a digital strategy for clinical investigations.
An eClinical platform built to exacting standards can ensure your pre and post market investigations are delivered smoothly and efficiently to meet your regulatory requirements.
Since the Date of Application (DoA), 26 May 2021, for MDR, manufacturers have a statutory requirement to collect post market clinical data as a continuous process over the device lifetime. The aims of Post Market Surveillance (PMS) under MDR are:
PMS is a cornerstone of MDR. With the explosion in the number of medical devices reaching the market since the turn of the century, it had become increasingly clear that existing compliance processes were no longer fit for purpose and that devices were achieving market entry without adequate clinical data supporting claims for safety – or efficacy.
If you have current data in paper, spreadsheet format or legacy databases, we can help. With CRFWEB we can develop an eCRF from that and import data, as appropriate allowing you to benefit from the efficiencies offered by our SaaS solution. If you are considering using spreadsheets as an alternative to an eCRF however, we strongly recommend you take advice first. An eCRF designed correctly on an EDC database like CRFWEB, with the requirements of Medical Device studies in mind, will make your study manageable and reportable. Deploy CRFWEB for these study types:
CRFWEB is a fast to set-up fully functioning, flexible, reliable and cost-effective SaaS EDC platform to manage medical device clinical studies. Its a critical part of your strategy to get your products to market. And a critical element to keep your products compliant post-market.
