Regulatory

One of the paradigms of the next generation computing tools is Augmented Reality (AR) where animated objects are superimposed on real-world objects. A live video or an image is initially scanned, detected, analyzed, and the required animated objects are added...

Few people outside of the industry know how big of a role the FDA has in product labeling and packaging. Every product approved by the FDA has very specific guidelines for its packaging and labeling, and these guidelines are often...

The De Novo pathway establishes new classification categories for novel low-to-moderate risk devices, which in turn allows similar devices to leverage the De Novo device as a predicate. In recent years, the De Novo pathway has proven to become much...

Imagine a platform where innovations meet modern healthcare services while following regulatory requirements. Such a platform is the Digital Health Center of Excellence (DHCoE) which is designed and governed by the FDA. Launched in September 2020, this platform is specifically...

FDA recently released a proposed rule that amends its existing regulations around establishing the intended use of a product and the evidence required for it. This proposed rule reopens the final rule that was issued on January 9th,2017 but which...

Programmable Logic Controllers (PLCs) are the components that are used for interfacing between multiple hardware devices or between a software and a hardware component. PLCs prove to be useful in mission-critical industries where a process is automated, facilitating increased productivity,...

Medical device manufacturers are responsible for not only developing safe and effective devices, but also ensuring that they continue to monitor the safety/effectiveness of the manufactured devices that are on the market. The requirement for post-market surveillance (PMS) was implemented...

Every medical device company should be familiar with the terms design verification and design validation. You will normally see these terms grouped into what is colloquially known as “V&V” activities, but medical device firms must understand the difference between the...