A new draft guidance document published by the US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) illustrates a voluntary process by which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

Medical device design and development is a process that helps to ensure devices that go to market are safe, effective, marketable, and profitable. The process is a blueprint of the phases needed to ...

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 ...

Plastics have long played a key role in enabling the design and production of numerous medical devices. But intensive work ...

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.

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 ...

Some medical technologies are just plain cool. But tech that’s only cool is never enough. It must solve specific health problems, improve each patient’s quality of care, and be easy to use. To create ...

The medical device industry is larger and more innovative than ever. Clinical research is experiencing a surge of innovation ...

Velosity Lab accelerates medtech launches with advanced tools, cutting lead times and driving innovation in medical device ...