Category: News & Blog

Digital health technologies such as wearables, connected medical devices, and Software as a Medical Device (SaMD) are massively transforming healthcare. Significant innovations in IoT sensors, smart devices, and other small communication devices are driving...

SaMD – THE POWER TO DIAGNOSE, TREAT AND HEAL USING SOFTWARE AS A MEDICAL DEVICE Author: Timothy Reynal SaMD:  SOFTWARE AS A MEDICAL DEVICE Software as a medical device, or SaMD, is a fast-emerging...

CAPA – Corrective and Preventive Action Within the medical device industry, if not carefully administered and messaged properly within the company, Corrective and Preventive Actions are often perceived by employees as “black eyes” on company performance....

If you’ve experienced an FDA recall, that’s usually enough grief & stress to last a lifetime. So, if you’ve dealt with several recalls (with the same company) it speaks to several likely challenges, and...