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

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

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 ...

Colombia has a population of approximately 50 million inhabitants, making it the third most populous country in Latin America after Mexico and Brazil. 1 Colombia's economy is the fourth-largest by ...

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 ...

Product labels that appear on device packages, admittedly, are not the most exciting part of medical device product design and development. They lack the excitement of scientific discovery, the cachet ...

Each clause contains the requirements as well as sub-clauses, which support the main clause by providing the details of the standard’s requirements for a QMS. For the purposes of this article, 21 CFR ...

Medical device manufacturers have traditionally focused on designing devices that are safe and effective to use. This will continue to be the main concern, but there is now more pressure on ...

At the end of 2019, the Digital Healthcare Act (Digitales Versorgungsgesetz, DVG) introduced a dedicated pathway enabling reimbursement of digital health offerings in Germany, bringing more ...

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, ...