In medical device development, things don’t go quite as you planned the first time around. This article shares what to really ...

As the use of medical device software and software as a medical device (SaMD) grows, regulatory bodies around the world are ...

Regulatory information management (RIM) software tools streamline global regulatory processes on a single cloud-based platform for managing regulatory submissions, tracking registrations, and ...

Periodically, standards are revisited by international and national committees to determine if they are still current or need revision or withdrawal. Through the voting process and based on comments ...

The uncertainty in patent eligibility has had a particularly chilling effect on patenting life sciences and computer software inventions. AI-driven innovations that lie at the intersection of these ...

Cardiovascular diseases are responsible for over 15 million deaths worldwide per year. 1 The occlusion of vessels such as the coronary or peripheral arteries hinders the flow of blood to the heart, ...

The digital revolution that resulted in the Internet of Things (IoT), Internet of Medical Things (IoMT), Software as a Medical Device (SaMD), and connected devices permeating the healthcare ...

There was a time when the inbound supply chain was perceived as a back-end operation, where no news was good news. Today, when supply chains are expected to provide real customer value, there are some ...

The laparoscopic device market is not confined to North America and Europe; but is experiencing substantial growth in Latin American and Asia-Pacific markets as well. The Latin American and ...

The FDA proposed on Feb. 22, 2022, an update to the Quality System Regulation 1 that was released in 1996. The proposal is to reference ISO 13485:2016 Medical devices — Quality management systems — ...