IEC 60601 is a generally recognized set of international guidelines for the fundamental protection and performance of electrical medical devices. It deals with the basic safety and essential performance requirements of medical electrical equipment, and serves to Read More...

In the area of medical technology, it is of uppermost importance to be keen in FDA regulation of medical devices. When you introduce technological advancements and developments to the medical device market, first your device must undergo all Read More...

Nowadays, it is difficult to imagine an ordinary person without a mobile device. The Internet has become available everywhere thanks to Wi-Fi and affordable cellular rates, so you can now stay online while at work, school, on Read More...

Case scenario 1 : Reliance on MedicalAC/DC adaptor with standard connector as means of protection against electrocution. Problem: Patient/operator uses standard ITE AC/DC adaptor. ITE AC/DC adaptor does not provide medical grade protection thus no such reliance is accordable. Possible solution: Use Read More...

We are convinced that all of you, dear readers of this blog, are experts in your specific fields. However, even the most experienced professionals not seldom underestimatethe most common development mistakes, such asthe absence of the consultation Read More...

What Is Medical Device Development Medical device development involves all stages from the conception of a product to releasing it in the market. The product may be an advanced x-ray machine, CT-Scan, MRI or any other medical device.  Read More...

Introduction to medical devices standards What is harmonization and what is the status of harmonization with MDR? So, what has changed? Lessons learned from recent submissions to NBs Common mistakes made during medical device development Introduction to Read More...