Are you compliant? Recent European MDR and IVDR regulations have made significant changes to compliance in the medical device industry and similar legislation is being brought in around the world. Not only do new Medical Device Trials require evaluation on grounds of safety and efficacy, but existing products are also required to demonstrate the same. The clock is ticking. CRFweb is proven in the medical devices field and can help facilitate a rapid turnaround of design and data entry for your investigation, whilst providing all the reporting outputs needed.
- FDA Compliant
- GDPR compliant
- Medical Device specific logs: AE, ADE, SAE, SADE, USADE
- Randomization for sham-controlled trials
A fast to set-up but fully functioning, flexible, reliable and cost-effective system to manage medical device clinical trials is no longer a nice to have. Its a critical element to get your product to market. And a critical element to keep your product compliant post-market.
The solution is now here. It’s tested, proven and currently helping medical device companies meet their compliance requirements.
It’s not too late to join them. Call now for a demo.