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...
On Monday, the FDA provided an update on its software precertification program known commonly as the Pre-Cert Program. This update comes over a year since the first working model of the pilot program was published by the agency, and nearly...
Hundreds of medical devices have been placed on the US market under an Emergency Use Authorization (EUA) to aid in the fight against COVID-19. Much like other medical devices that follow a more routine regulatory pathway, devices under an EUA...
Drug facility pre-approval inspections are required to grant a complete response letter from the FDA to get a new drug application approved. FDA understands that some facilities which are located in regions impacted by COVID-19 may have some travel restrictions...
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...