MEDIcept Insights
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...
In Vitro Diagnostic Regulation Update
In less than 430 days, the In Vitro Diagnostic Regulation will fully replace the EU’s current Directive on in vitro diagnostic medical devices (IVDD 98/79/EC). Are you prepared for the transition? What is In Vitro Diagnostic Regulation (IVDR)? The IVDR is the new...
Telemedicine: How the pandemic has changed healthcare services
While telehealth technology and its use are not new, trends show some increased interest in the use of telehealth services by both healthcare professionals (HCP) and patients. Due to the COVID-19 pandemic, changes in the way that healthcare is delivered are being...