A 510(k) is the most utilized regulatory pathway to market a medical device in the US. For a device of the same level of risks, a CE Mark is required to market a medical device in the European Economic area. In...
If you’re considering selling your medical device in Europe, you will need a Notified Body, and you’ll need to understand what role they play in making sure your device is compliant to the EU regulations. A Notified Body is an...
With the up-classification of medical devices as per the new EU MDR, software used as a medical device has been affected the most. Under Rule 11: “Software intended to provide information which is used to take decisions with diagnosis or therapeutic purposes...
The new EU MDR and the new IVDR have some harmonized standards also known as recognized standards. The harmonized standards are those that are referenced in the Official Journal of the European Union. Devices that comply with these harmonized standards...
ISO 14971 is the ultimate gold standard for risk management for medical devices. It was developed to provide manufacturers a process to assist in identifying the hazards associated with their devices, the health risks they possess and how to effectively...
Are you working with a product whose fitness for use or quality deteriorates over time? Does your Quality Management System support identification and controls of products storage and distribution requirements between following manufacturing and until placed in-service? The Quality Management System...
With less than a year until the end of the EU MDR transition period, it is pertinent to ensure that all devices to be sold in Europe comply. We’ve been highlighting many of the new requirements in our blogs, including: INTRODUCTION...
With the mounting tensions that the new EU MDR has put on medical device manufacturers, the ripple effects can be seen in every department at those medical device companies. By default, the regulatory affairs functions have been the worst hit and...
With the new EU MDR, companies must comply with several new requirements. Our previous blogs gave a snapshot of what has changed in the new EU MDR and how as a Medical Device manufacturer you can best deal with these...
In December 2018, the U.S. Food and Drug Administration formally recognized a public database that contains information about genes, genetic variants, and their relationship to disease. This blog discusses the motivation for creating such public databases and the implications for...