Requirements

The platform of Robotics facilitates automation in any industry. It uses various streams of Engineering including Computer Science, Electrical, and Mechanical, and is primarily used to build intelligent machines where human safety is of major concern. Generally, the major components...

For the past few decades, the FDA has been attempting to increase the diversity of individuals participating in clinical trials. Specifically, they are trying to encourage any companies conducting clinical trials to include the demographics that will primarily be using...

If you are a part of the medical device industry, you are probably familiar with just how many “must know” acronyms exist. Three of the most important, and most often confused, acronyms are DHF, DMR, and DHR. The Design History...

It is no secret that brand-name drugs in America are often expensive. Luckily, for the many American’s who are not able to afford those brand-name drugs, generic drugs are an option. Most people are somewhat familiar with the concept of...

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,...

Health Canada released a new notification on requirements for companies intending to manufacture face shields during the pandemic. Face shields are considered personal protective equipment (PPE) that helps in preventing exposure to particulates that spreads infectious diseases. A face shield...

Back in May, the FDA announced its intention to re-start domestic routine inspections (which you can read more about in our blog here). Last week, the FDA announced that it is planning to restart some on-site surveillance activities the week...

The EU Commission committed to provide information on the availability and the capacity of the notified bodies to conduct conformity assessments in the Joint European Roadmap towards lifting COVID-19 containment measures released on April 15, 2020.1 The EU commission conducted...