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, ...

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 ...

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 ...

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 ...

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 ...

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 ...

The medical device market in India is one of the best places for the world to tap into since the early 2000s. Many are watching the evolution of the medical device industry in India, with McKinsey and ...

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 ...

Several years ago, ISO requested that the national standards committees review ISO 14971:2007 — the current international version — to determine whether it needed updating and improvement. The request ...

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 ...