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...
FDA Cleared vs FDA Approved. Let’s dive in! There’s a big distinction between a drug or medical device that’s been FDA cleared and those that are FDA approved. Given that more and more medical device products are...
A lot of clients ask us about SDLC Process Improvement and what does it mean. What is the Benefit of a ‘best practice’ SDLC? A properly implemented software development lifecycle (SDLC) can make all...
