IEC 60601 is a generally recognized set of international guidelines for the fundamental protection and performance of electrical medical devices. Compliance with the current version of medical devices 60601 must be shown by your new and existing medical Read More...

In the area of medical technology, you have to hear about laws on medical devices FDA. Whether you represent the industry, and this is an industry that is more compliant and legislative. When you introduce technological advancements and Read More...

Nowadays, it is difficult to imagine a modern 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: 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 protectionthus no such reliance is accordable. Possible solution: Use of Medical AC/DC Read More...

I am sure that all of you are experts in your field, the most common development mistakes are underestimating knowledge and experience of other discipline. Collaboration and sharing of experience between development and regulation department can bring 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 or MRI.  Launching a 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...