FDA's quality system regulation (QSR) details specific activities that mustoccur for a new medical device to be made and commercialized in theUnited States. QSR requirements govern “the methods used ...

Many medical device companies develop software using a traditional waterfall methodology in which each step is taken in sequence: requirements, design, implementation, verification, and validation ...

A new draft guidance document published by the US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) illustrates a voluntary process by which companies can qualify ...

The Food and Drug Administration (FDA) development and approval process for drugs and medical devices involves multiple phases that ensure the safety and effectiveness of products before and after ...

Learn best practices and proven strategies to address challenges presented by today’s shifting regulatory environment and the keys to commercial success. This is an On-demand recording from July 2020.

Opinions expressed by Digital Journal contributors are their own. The advent of artificial intelligence (AI) and data-driven methodologies has triggered a wave of transformation in regulatory ...

Medical device design and development has evolved over the years, notably influenced by market demands and regulatory requirements. Traditional design practices, beginning with a reliance on generic ...

Whether developing a new device or improving an existing one, STEMart has the experience to help clients address the design, engineering, manufacturing and regulatory challenges unique to the medical ...

Device makers are taking increased interest in product designs and assembly that support closed-loop recycling. A Branson plastic welding process can safely and nondestructively “unweld” plastics used ...

The Master of Engineering (M.Eng.) in Medical Device Development is a cutting-edge program that promises to accelerate the career development of aspiring engineers in all disciplines who wish to pivot ...