Many medical device companies want to go to Japan since it is the third-largest market in the world. Oftentimes, device companies want to register their devices quickly in Japan to be on the market ...

Annex IV (EC Declaration of Conformity – Full Quality Assurance System) of the IVDD (98/79/EC) is all about delineating specific regulatory requirement for devices falling under List A of Annex II.

An increasing number of medical devices incorporate artificial intelligence (AI) capabilities to support therapeutic and diagnostic applications. In spite of the risks connected with this innovative ...

Artificial intelligence (AI) has become a commonplace reality as technology advances. Healthcare is one sector that is quickly changing on a big scale. From the issuance of electronic healthcare cards ...

As has been widely noted, the COVID-19 pandemic has prompted countless people to rely on telehealth and virtual monitoring for their healthcare needs. This dramatic pivot is catalyzing a demand for ...

The healthcare industry is a complex web of clinical, administrative, regulatory, and financial processes. Despite the advancements in health information technology and artificial intelligence, ...

Fabricio Pamplona, Ph.D., is the founder of Mind the Graph, an online platform that offers thousands of accurate medical illustrations that users can download. Pamplona has a background in ...

EU MDR required companies to make significant changes to their medical device labels, highlighting the need for a well-coordinated and agile device labeling process. We spoke with Laura Johnson, ...

The global medical device industry is growing rapidly and poised for steady growth. According to the Facts and Factors market research report, the global medical devices market size and share revenue ...

Corrections, corrective actions and preventive actions are the “their, there, and they’re” for many medical device organizations. Confusing them is common, and even experienced and knowledgeable ...

Fueled by a near-constant stream of advancements in technologies and treatments, increased healthcare spending and a strong economy, the medical device industry is growing dramatically with no end in ...

Dhaval Shah, Executive Vice President and Market Head, MedTech, at CitiusTech, is responsible for developing the vision, capabilities and solutions for partnering with leading healthcare and life ...