Government-led industrial policies and rapid technological advancements are reshaping market dynamics for medical devices in ...

As the timeline for commercialization closes in, it’s necessary to best position the organization for a successful launch.

Connected drug delivery devices integrate digital connectivity — often via Bluetooth — with traditional drug administration ...

Vertiva™ is an on-body delivery system platform composed of a single-use pod with pre-filled and pre-loaded cartridge and a multi-use, smart controller. The platform offers a wide range of performance ...

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 ...

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 — ...

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, ...

In recent years, the digitalization of the healthcare industry has been accelerated to meet demands for smarter devices and robotics, wearable technology, AI-based data analysis, and enhanced ...

Every new medical device feature must live within a quality management system that tracks design control, risk management, ...

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 ...

This is the second article in our three-part article series on postmarket change controls and implementing a Predetermined Change Control Plan (PCCP) for Class II Software as a Medical Device (SaMD) ...

The proposed FDA regulation for laboratory developed tests (LDTs), as outlined in FDA-2023-N-2177-0001, marks a significant step toward the FDA trying to standardize oversight for these diagnostic ...