Getting an FDA approval for your medical device can be a stressful task especially if you are new to the

Introduction In the ever-evolving landscape of medical device regulation, obtaining approval for In Vitro Diagnostic Devices (IVDs) can be a

Yearly FDA Renewal for Medical Device Operon Strategist guides clients through the complex and ever-evolving regulatory landscape of the healthcare

What is Establishment Registration? Every medical device manufacturer and distributor is required to register their organization with the FDA before

Incorporating Artificial Intelligence into Medical Products: The FDA’s Strategy On March 15, the U.S. Food and Drug Administration (FDA) released

FDA Guidance on AI-Enabled Medical Devices: An Overview The FDA is reshaping how the medical device industry approaches Artificial Intelligence

The world of medical devices is a rapidly evolving landscape, constantly pushing the boundaries of innovation to enhance patient care

Design controls for medical devices demonstrate that the medical devices are safe, effective, and meet the indications for use. A

FDA Medical Device Classification states that a CLASS I MEDICAL DEVICE, as well as Class II and III, are “an

In recent years, the medical device sector has seen great innovation and growth, with more than 200 million medical devices