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 ...

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 ...

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 ...

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 ...

Medical device manufacturing is a high-stakes game where efficiency meets precision. With tight regulations, complex designs, and a need for speed, how do companies stay ahead without cutting corners?

When the Federal Drug Administration (FDA) updated the provisions for medical device cybersecurity, one of those required the development of a software bill of materials (SBOM). It’s now mandatory for ...

STEMart, a US-based provider of comprehensive services for all phases of medical device development, has announced the availability of its robust In Vitro Micronucleus Test service to meet the ...

The U.S. Food and Drug Administration (FDA) categorizes medical devices into three classes based on the level of risk the devices pose to patients and users. Image Credit: IGORdeyka/Shutterstock.com ...