Meeting FDA requirements for secured medical product and solutions
Manufacturers for medical devices, accessories or wellness trackers are trusted by hospitals, caregivers, patients and general consumers to deliver proper medical care and attention. As technology advances and integrates within medical products, a heightened risk factor is formed through transmission of personal data, functionality and delivery of critical care. Now more than ever, manufacturers and product developers need to be certain their healthcare product not only meets federal regulations (such as those set forth by the FDA), but has been evaluated against common threats and vulnerabilities.
We work to first understand your product while outlining the best evaluations or potential certifications that will enable you to be best positioned for market success. A few common standards and test types include:
This standard is specific to medical devices, accessories, data systems as well as wellness devices. In mid-2018, the United States FDA officially recognized the UL 2900-2-1 standard as demonstrating the safety of network connected devices.