MEDIcept Insights
Postmarket Management of Cybersecurity in Medical Devices
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.
How can I benefit from Quality Assurance Services?
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...
What is Due Diligence?
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...
Premarket Submissions for Management of Cybersecurity in Medical Devices
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...
Developing, maintaining, and implementing written MDR procedures
With the issuance of the Draft Guidance FDA Notification and Medical Device Reporting for LDT late last year, there have been a number of clarifications in its first major attempt to update the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...
Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling
The U.S. Food and Drug Administration recently published a final guidance focusing on reprocessing of reusable medical devices. The new recommendations contained in the guidance are intended to help manufacturers develop safer reusable devices. Medical devices...