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 ...

Assessing the chemical makeup of a medical device as part of the safety evaluation can either be a blessing for manufacturers by shortening the time to market or entail some surprises, according to ...

At the upcoming MD&M East show in New York City in May, Janet Kwiatkowski, MBA, MSRA, president and CEO of MAE Group, will give a talk entitled “Importance of Early Dialog & Interaction with the FDA.” ...

April 9, 2010 — In its latest effort to reduce the risks of medical radiation, the US Food and Drug Administration (FDA) yesterday notified manufacturers of radiotherapy equipment such as linear ...

FDA approval describes when the Food and Drug Administration (FDA) deems a medical product safe and effective for its intended use based on scientific data and testing. Before people use a medical ...

The advent of artificial intelligence (AI) and data-driven methodologies has triggered a wave of transformation in regulatory compliance and quality assurance for the development of medical devices.

WEST CHESTER, Pa.--(BUSINESS WIRE)--Archimedic, a medical device development firm that provides Design, Regulatory, and Go-to-Market services to its clients, has launched OpenQMS, an open-access, ...

OrthoPediatrics Corp. has announced its partnership with the Crossroads Pediatric Device Consortium (CPDC) to enhance the development of innovative pediatric medical devices. This multi-institutional ...

Ketryx Corp., a company transforming product lifecycle development and compliance for medical device makers with artificial intelligence, today announced it has raised $39 million in a Series B ...

Discover how software developers for medical-device OEMs are balancing innovation and safety, and the challenges they face in making it happen. The medical-device industry is rapidly advancing, from ...