FDA

The Emerging Medtech Summit 2020, organized by Life Science Intelligence, saw over 100 innovative medical technology startups from a multitude of medical modalities present their cutting-edge innovative technology and their plan for growth to gain strategic partnering and investment. The event...

Annex I under the EU MDR, General Safety and Performance Requirements, outlines some broad requirements that are applicable to all devices. Manufacturers need to carefully read and understand each requirement since only some of them will apply to any given...

How does gene therapy fit into the FDA? Is it a medical device, a drug, or a combination product? What if gene therapy can cure a life-threatening disease? There are a lot of questions that can pop into your mind...

Are you looking to expand your consumer base and grow your business? International marketing is beneficial by creating long-term business relationships and increasing brand reputation. Expanding your market to a country like Australia is a smart commercial move, but how...

Whenever there is a public health emergency, such as the Zika virus in 2016 or the current novel coronavirus, there is a rush to get diagnostic tests and other medical products to detect and treat the emergency available quickly. Given...

An institutional review board, or IRB, is a group of experts who are appointed to monitor and review biomedical research involving human subjects at a facility. An IRB plays an important role for medical device manufacturers as they will oversee...

Augmented and virtual reality first saw its boom in the consumer sector but has recently piqued the interest of the medical device community. Extended reality (or XR, the umbrella term for augmented or virtual reality) can have many uses across...

Laying out a regulatory strategy for your product that visualizes the steps taken to bring a new or modified product to market could be one of the smartest decisions you can take as a start-up company. The regulatory strategy describes...

The FDA released two final rules surrounding the classification, and the requirement to submit a pre-market notification, for some medical devices. The final rule that went into effect on December 30,2019 adds to the current list of class I and class...

Recently, 3D printing technology has seen a boom in popularity among many different industries, including medical devices. 3D printing medical devices allow manufacturers to easily create devices that function with a patient’s anatomy (also known as patient-specific devices). For this...