February 24, 2023
Global healthcare systems require medical devices that are safe and effective in the diagnosis, treatment and prevention of diseases, and physicians rely on a wide range of medical devices to help identify and treat said ailments. However, for medical devices to be considered both safe to use and effective for […]
October 14, 2022
An Investigational Device Exemption (IDE) is an application submitted to obtain the FDA's approval for use of a novel medical device in a clinical study. This allows for the collection of safety and effectiveness data in order to support full market approval. IDE applications support several types of studies: to […]
August 8, 2022
You've likely heard the phrase “time is money.” No other statement could be more accurate for the medical device industry. Each day your company is not approved to market your device is not only a day of lost revenue, but a day patients don’t get to benefit from the value […]
June 7, 2022
Medical devices have been saving lives for decades. And medical devices are quickly changing as new technology such as 3D printing, software, hardware and algorithms are being incorporated into device designs. Medical devices are not simply band aids and thermometers any longer. They are sophisticated designs that help people with a myriad of problems and in many cases, they prolong and save lives.
June 1, 2022
Audits are necessary. However, just as we learned during the COVID-19 pandemic, that many people could perform their jobs perfectly well without getting in their car or on a train to come to the office, we have also seen that many audits can be done well…virtually. There is a place for both virtual and on-site audits.
