Industry Articles

Learn What Breakthrough Device Designation Is & Why the Automatic BDD Reimbursement Been Paused by the Centers for Medicare & Medicaid Services (CMS).‍

So, you have an idea for a medical device, and you obviously want to take it to the market so that it can have a positive impact on tons of people’s lives and maybe make you a little money as well.

When surveying the myriad of pre-clinical testing required to bring your medical device to market, we understand it can be daunting.

Read "Why Understanding Regulatory Affairs is Important to key Company Decision Makers" By Isabella Schmitt, RAC in the latest Regulatory (RF) Article Series.

The FDA introduced a new, voluntary program “Ethylene Oxide Sterilization Master File Pilot Program” that accelerates the documentation processes for sterilization providers and device manufacturers.

The FDA’s new draft guidance on clinical decision support software (CDS) is a major revision of a prior draft guidance issued on December 8, 2017. It explains the FDA’s method of interpreting section 520(o) of the Federal Food, Drug, and Cosmetic Act

In December 2018, FDA announced plans for a new program--the Safer Technologies Program, also known as STeP, and on September 18, 2019, draft guidance for the STeP program was released.

At Proxima Clinical Research, our clinical project managers are here to help you foresee the potential risks in your study as well as help you fix or avoid them altogether.

You don't think you need a CRO quite yet? Think again.