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...
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...
Approximately 463 million people on Earth are affected by Diabetes, a disease in which the body’s ability to produce or use the produced insulin to regulates blood glucose levels is impaired.1 Consistent high glucose levels can lead to serious conditions...
The Application Programmable Interface or the API is the modern data access tool for developers. It acts like middleware or a software intermediary that allows two applications to talk to each other in terms of data. Data is an important...
Computational Intelligence (CI) is one of the major pillars of Artificial Intelligence. It is the study, design, and development of intelligent software based on the theory of evolution. Within the past decade, healthcare has become expensive. Also, with the declining...
The long-awaited Brexit is set to take place on December 31st, 2020. This is when Britain will exit the European Union after the 1-year transition period which is currently ongoing. In preparation for the exit, the UK MHRA released a guidance...
It may seem straightforward to determine if a product is a medical device or not but there is a surprising amount of gray-area in the field. The term “medical device” covers a simple tongue depressor to an implanted pacemaker and...
The COVID-19 pandemic is still creating headlines in the health care domain. Around the world, governments, and organizations such as World Health Organization (WHO), European Medical Agency (EMA), and FDA are working together to eliminate lockdowns and get our society...
For the most part, everyone in the medical device industry is familiar with the term “510(k)”, but not many people know that there are three different types of the premarket notification. The following are the different types of 510(k)’s a...
FDA’s Center for Devices and Radiological Health’s (CDRH) Office of Science and Engineering Labs (OSEL) released a list of regulatory science tools to help the industry in new product development. The Office of Science and Engineering Labs is a part...