3D Printing of Medical Devices at the Point of Care
FDA Action on 3D Printing of Medical Devices at the Point of Care In the medical device field, manufacturers and regulators are constantly trying to balance the advantages of new and emerging technologies with the complex, and often lengthy, regulatory process to ensure the devices are safe and perform as they are supposed to. This […]
FDA Medical Device Regulation Guidance for 2022
In the United States, the U.S. FDA (Food and Drug Administration) provides medical device regulation through the CDRH (Center for Devices and Radiological Health). The agency recently released its proposed FDA medical device regulations for 2022 indicating a heavy focus on software as related to medical devices. Here’s a breakdown of the ones we think […]
Medical Device Safety Standards
Approaching Medical Device Safety Standards Compliance In the United States, medical device companies that manufacture, repackage, relabel, and/or import medical devices sold in the U.S. are regulated by the Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH). To be cleared or approved for sale, devices must adhere to outlined medical device […]
Preparing for GLP Guideline Regulations in Medical Device Development
Preparing for GLP Guideline Regulations in Medical Device Development As you begin the process of designing, developing, and manufacturing your medical device, there are many things you must consider in the early stages to ensure your device can ultimately be approved by the relevant regulatory body, make it to market, and improve the health and […]
Minimally Invasive Devices
An Overview of Minimally Invasive Devices Minimally invasive devices have revolutionized the medical device industry. Using minimally invasive technology has improved patient outcomes and recovery all over the world. As their success rises, so does their popularity. So, it’s no surprise that the minimally invasive device market was worth an estimated $20 billion as of […]
Avoiding Medical Device Failures and FDA Recalls: Use an Experienced Medical Device Engineering Firm
Avoiding Medical Device Failures and FDA Recalls: Use an Experienced Medical Device Engineering Firm By manufacturing and providing a medical device, you are taking on a big responsibility. If your product experiences medical device failure, a patient could receive an inaccurate diagnosis or treatment, get injured, or even lose their life. Medical devices in the […]
The COVID-19 Pandemic and 510(k) Clearances
The global COVID-19 pandemic, and the subsequent public health emergency it created, changed much about our everyday lives, and the medical device industry is no exception. To respond quickly to the health need and provide the American public with expanded access to certain medical devices, the U.S. Food and Drug Administration (FDA), the government body […]
The Use of Artificial Intelligence in Medical Devices
Artificial intelligence (AI) is a powerful and ever-emerging technology that has the potential to improve capabilities across a multitude of industries. Medical devices with artificial intelligence hold the promise of revolutionizing the health care industry, helping medical professionals more accurately and effectively diagnose and treat their patients and improve their overall care. Along with its […]
A Guide to FDA Design Controls for your Medical Device
Medical devices hold great responsibility and risk – if they aren’t working properly, there could be dire consequences for a person’s health and potentially life. Because of this, they are highly regulated in the United States by the Food and Drug Administration (FDA). To be approved by the FDA, your device must effectively diagnose and […]