CE Certificate Vs Declaration of Conformity — I3CGLOBAL

When it comes to placing products on the…

Shelf Life of Medical Devices FDA

In the realm of medical devices, ensuring their safety, efficacy, and integrity is of paramount importance. The concept of shelf life plays a crucial role in this regard, dictating the period during which a medical device retains its intended functionality and quality.

Class 1 Medical Device Registration Path

Class 1 medical devices, the lowest risk category, include items like bandages, tongue…

Performance Evaluation Plan for Medical Devices: A Blueprint for Safety and Quality

Medical Device Usability: Enhancing User Experience and Patient Safety

FDA Q Submission Example

FDA Q Submissions encompass a range of interactions, including Pre-Submission Meetings, Informational Meetings, and…

Clinical Evaluation of New Drugs

The development of new drugs is a complex and rigorous process that involves several stages of…

Notified Body Review process of CER Documents

In order to demonstrate that a device complies with the essential requirements…

Understanding CE Marking for Medical Devices: Ensuring Compliance and Market Access