The story I’m about to tell you is about Eddy Engineer and his trials and tribulations of bringing a new medical device to market. Have you ever had or been part of a new and exciting idea? An idea ...

Expertise from Forbes Councils members, operated under license. Opinions expressed are those of the author. Fueled by convenience, fashion, size and technical innovation, medical devices have evolved ...

FDA has published and makes available ALL regulations required for medical device companies. Look them up by searching 21 CFR part 820. And for outside U.S., you can easily obtain ISO 13485 for a ...

As part of our Spotlight series, Dennis C. Gucciardo, who counsels medical device manufacturers throughout the product lifecycle in the US Food and Drug Administration (FDA) regulatory context, shares ...

Medical device innovations have enhanced healthcare and improved patient care, but they present a broad attack surface for healthcare organizations. NetSPI, a security service company, hosted medical ...

The court concluded that the defendant's duty to defend emergency response systems provider Medical Guardian was triggered ...

Certain Philips' patient monitoring products are the subject of new security alerts from the manufacturer and CISA. Federal regulators and Philips this week issued advisories pertaining to several ...

Implanted neurostimulator medical device approved under FDA’s premarket approval regulations (PMA) gave plaintiff a shock which allegedly caused a fractured hip. Plaintiff’s claims of strict liability ...

LONDON, Dec 19 (Reuters) - Nicola Osypka's German company has been selling medical devices used in surgery on newborn babies in Europe for decades, but new European Union rules have forced her to make ...