MEDIcept Insights
The Latest Updates to FDA’s COVID EUA’s
The COVID-19 pandemic has made obscure regulatory procedures big news across the globe. Chief among these is the Food and Drug Administration’s (FDA) Emergency Use Authorization (EUA) authority, the expedited pathway through which COVID-19 vaccines were authorized....
Speaker Program Fraud: What You Need to Know to Protect Yourself
The healthcare industry can be full of tempting offers, many perfectly legal, though there are some that are not. To make matters more difficult, illegal ones can appear above-board and acceptable when, in fact, some aspects of them pose a significant legal risk to...
Artificial Intelligence and Medical Devices
Growing numbers of medical devices are using artificial intelligence and its associated technology—machine learning—to diagnose patients more precisely and treat them more effectively. Although many devices have already been cleared by the FDA, many regulatory...
MDR Transition: What does it mean for your company?
On May 26 the new Medical Device Regulation (MDR) will replace the previous Medical Device Directive (MDD).
Eudamed Update: Implementation is Paused, MDR Compliance is Not
The new European medical device database, known as Eudamed, was originally scheduled to launch in May 2020, but the pandemic caused its implementation to be delayed two years, until May 26, 2022. However, that does not mean that compliance considerations are on hold. ...
How the Pandemic Affects MDSAP Audits
The Medical Device Single Audit Program (MDSAP) has been a blessing for many medical device manufacturers because it has allowed third-party auditors to conduct a single audit of a medical device company to satisfy the regulatory requirements of the five countries...