CE marking is mandatory for marketing medical devices and in vitro diagnostics (IVDs) in the European single market, comprising all European Union (EU) member states and European Economic Area (EEA) countries. With the introduction of the EU Medical Devices Regulation...
Premier Research
Premier Research exists for one reason: To transform life-changing ideas and breakthrough science into new medical treatments. We care about improving human health and that starts with the health and wellbeing of our own team members, not only by offering...
You found an exciting role at Premier Research and have scheduled an interview. Amazing! Now you need to make a good first impression. It’s natural to be a little nervous, but you are up to the challenge. These 9 tips...
The FDA's January 2020 guidance, Chemistry, Manufacturing and Control (CMC)[1] Information for Human Gene Therapy Investigational New Drug Applications (INDs), outlines the analytical methods that define the quality, safety and efficacy of gene therapy therapeutics. The analytical package, consisting of...
CE marking provides access to a market of over 500 million consumers across all 27 member states of the European Union (EU), as well as Iceland, Norway, and Liechtenstein. For medical devices and in vitro diagnostics (IVDs), a CE mark...
Medical Device
5 Stages of Medical Device Development
Medical device development must address some unique challenges that have grown over the last decade due to increasing medical device complexity, a more complex regulatory framework catching up with the industry, and an established and variable standard clinical practice to...
Rare Disease
Why Rare Disease Day Matters to Us
An estimated 300 million people globally suffer from a rare disease. Further still, 25 million people in the U.S. alone are living with an undiagnosed rare disease. Limitations in disease understanding and lack of approved treatments can mean countless challenges...
“You have cancer.” It’s something you hope to never hear. For so many of us at Premier Research, we’ve watched loved ones fight for their lives — or fought for our own. That’s why we choose to work at Premier,...
In the past, medical device developers often chose to bring new products to market in the EU first since obtaining a CE mark was perceived to be faster, less expensive, and more predictable than securing US FDA clearance or approval....
An investigational device exemption (IDE) allows an investigational device to be used in a clinical study to collect safety and effectiveness data.[1] However, if certain criteria are met, many in vitro diagnostic (IVD) devices are released from IDE regulations. This...