Archive
Why is Medical Device Compliance so Important?
Posted on January 21, 2022 by DeviceLabMedical device companies have to comply with many different regulations with US regulatory agencies and globally. At times this can feel burdensome and overwhelming; however, manufacturers should keep the bigger picture in mind and build regulatory compliance into their company’s culture. Ensuring regulatory compliance can provide companies with the assurance their product is safe for […]
FDA Classification Overview: Class III Medical Devices
Posted on January 7, 2022 by DeviceLabPreviously we’ve discussed FDA Class I medical devices, which are the lowest levels of risks. But what about medical devices that are the riskiest or have the most unknown risk? The FDA regulates medical devices based on the risk-benefit profile. Medical devices with a higher risk profile or lower perceived benefits are classified as Class […]