AssurX streamlines electronic medical device reporting (eMDR) for FDA compliance. Our platform automates data formatting, validation, and submission, ensuring timely and accurate reporting. Enhance your regulatory processes with real-time status updates and seamless integration for global compliance.
As regulations and standards evolve, one trend is continually sharpening in focu [...]
After a one-year delay due to concerns over a shortage of notified bodies, the n [...]
Three recent warning letters from the Center for Device and Radiological Health [...]
First-quarter 2017 Food and Drug Administration (FDA) warning letters emphasize [...]
Risk management and adverse event reporting protocols for medical device manufac [...]
FDA FastStats: CDRH Shows Significant Growth in Electronic Submissions; Deadline [...]
In our latest round-up, it was the District Offices turn to chime in on medical [...]
Jeff Mazik, Vice President, Life Science Solutions, AssurX If you have been pr [...]
Medical device manufacturers would be well-advised to address any potential home [...]
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