North America
As the benefits of software become increasingly present to healthcare systems, its risks do too. While software can increase the efficiency and effectiveness of healthcare, it can also create greater vulnerabilities. The medical device industry in particular has had...
North America
The FDA is in the process of implementing the Unique Device Identification (UDI) System in a series of phases. Currently, all Class III and implantable, life-supporting and life-sustaining medical devices require UDIs. The next phase of the system will be implemented...
North America
Mobile health app The growing significance of mobile health apps result in a need to ensure its proper regulation. Practitioners, patients, researchers and medical industries are all affected by mHealth apps. The digital health field is regulated by the FDA under four...
North America
The difference between CLIA and FDA standards
North America
The FDA has announced an increase in fees for assessing and exporting medical devices. The FDA Export Reform and Enhancement Act of 1996 enables manufacturers to request that the FDA issue a certification stating that their device meets certain requirements within 20...
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