MDR

The new European Medical Device Regulations and the In Vitro Diagnostic Devices regulation have a lot emphasis on the post-market activities that a manufacturer must undertake. With the clock ticking fast to meet the deadline for the transition period, which...

One of the major changes with the EU MDR that medical device manufacturers will feel as they transition to comply with the new regulation is the change in requirements for device classification. As medical device classifications change so do the...

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...