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 ...

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 ...

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 ...

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 ...

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 ...

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 ...

At a time when medical technology breakthroughs often stall long before reaching patients, Northwestern University’s Querrey Simpson Institute for Bioelectronics (QSIB) has become a striking exception ...

In recent years, pharmaceutical companies have broadened their horizons, moving beyond drug development to enter the medical device market. This strategic shift allows pharma to offer integrated ...

Eclypsium security researchers have uncovered UEFI vulnerabilities in the Illumina iSeq 100 DNA sequencer, but the broader issue involves the device development process at large. In highlighting ...