Whenever there is a public health emergency, such as the Zika virus in 2016 or the current novel coronavirus, there is a rush to get diagnostic tests and other medical products to detect and treat the emergency available quickly. Given...
An institutional review board, or IRB, is a group of experts who are appointed to monitor and review biomedical research involving human subjects at a facility. An IRB plays an important role for medical device manufacturers as they will oversee...
Augmented and virtual reality first saw its boom in the consumer sector but has recently piqued the interest of the medical device community. Extended reality (or XR, the umbrella term for augmented or virtual reality) can have many uses across...
Recently, 3D printing technology has seen a boom in popularity among many different industries, including medical devices. 3D printing medical devices allow manufacturers to easily create devices that function with a patient’s anatomy (also known as patient-specific devices). For this...
The updated version of ISO 14971, Application of Risk Management to Medical Devices, has officially been published this month; this is an update to the previous versions, ISO 14971:2007 and EN ISO 14971:2012. The major changes include reorganization of the...
For manufacturers of medical devices, it can be an easy trap to fall into only focusing on the compliance of your device and forgetting your supply chain. The FDA has strict regulations around Purchase Controls (supplier management) that are outlined...
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...
If you are developing a medical device, you will need to become familiar with Design Controls. 21 CFR 820.30 states that every class III and class II medical device manufacturer “shall establish and maintain procedures to control the design of...
Do you have a medical device that treats or diagnoses a life-threatening disease? If yes, your device may be eligible for an expedited review pathway called the Breakthrough Devices Program. The FDA defines a breakthrough device as any device (or...