MEDIcept Insights

The area of genetic testing has expanded recently with more types of testing becoming available for both clinical and non-clinical applications.

Many medical devices currently in commercial distribution today incorporate some type of software. Some devices use software to control certain aspects of the device or perform data analysis while others use it to connect to the Internet and health care provider networks for monitoring and sharing data.

Quality assurance (QA) is a crucial part of any medical device manufacturing and assembly process. When you’re providing a product or service, health care professionals expect you to deliver exactly what they need without any flaws or mistakes. Providing poor quality...

Due diligence is a concept that has been around for a long time. In basic terms, it means doing your homework before making any major decisions about finances, investments, equipment, or more. For medical device manufacturers, it often involves a little more work in...

The same data management technology used in consumer devices such as personal computers, smartphones, and tablets is increasingly being found in medical devices and is used to manage and transfer critical health information over wireless networks. To address the...

With the issuance of the Draft Guidance  FDA Notification and Medical Device Reporting for LDT late last year, there have been a number of clarifications in its first major attempt to update the Medical Device Amendments (MDA) of the landmark Federal Food, Drug, and...