Tag: regulatory requirements

Medical and Regulatory Affairs

The Regulatory Landscape of Software as a Medical Device

So much of the medical world is about data, and as healthcare data continues to play an increasing role in the “big data” landscape, the challenge is figuring out how to use it properly within the healthcare ecosystem. A new class of medical software known as Software as a Medical Device (SaMD) is offering innovative ways to capture, optimize and analyze healthcare...

Medical and Regulatory Affairs

Medical Device Trials: What You Need to Know About U.S. Regulations

While clinical investigations of medical devices and investigational drugs have their differences, what they do have in common is the goal of safeguarding the rights and welfare of study participants while bringing safe and effective products to market as quickly and efficiently as possible. Not all medical devices require a clinical trial, depending on their...

Clinical Research: Phase 1 - Phase 4

Informed Strategy Key to Drug Development Innovation, Premier Research Says in Naming Regulatory Chief

DURHAM, N.C., June 27, 2016 — Small biotechnology companies taking new biopharmaceutical products from benchtop to bedside need an informed regulatory strategy and a close working knowledge of the Food and Drug Administration and other regulatory agencies. So when it sought a new head of regulatory affairs, clinical development service provider Premier Research found its ideal...