Medical Devices

June 1, 2022

Virtual Audits of Medical Devices

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.
June 7, 2022

The Ever-Changing Medical Device

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.
August 8, 2022
Medical Device Strategy

How A Global Regulatory Strategy Creates Pathways for Medical Devices

You have heard the phrase “time is money.” No other statement can be more accurate for the medical device industry than this one. Every day you are not approved to market your device is a day of lost revenue. But unfortunately, it is also a day that patients don’t get […]
October 14, 2022
Investigational Device Exemption Study

What Is An Investigational Device Exemption Application and Study?

An Investigational Device Exemption (IDE) is an application submitted to FDA to obtain their approval to use your novel medical device in a clinical study in order to obtain safety and effectiveness data to support a full market approval. There are several types of studies: early feasibility (i.e., a study […]