Utilizing design for manufacturing (DFM) and tools such as Moldflow® simulation software is also common, but like any process ...

Examining the evolving dynamics between EU and FDA regulations for medical devices. The webinar will address the historical practice of obtaining a CE Mark in Europe first, contrasting it with the ...

In November 2023, B. Braun Medical initiated a correction of its Infusomat Space Large Volume Pump wireless, and Infusomat Space Large Volume Pump non-wireless battery pack after reports of faulty ...

This week, FDA issued a safety communication connected to Zimmer Biomet’s CPT Hip System Femoral Stem after finding increased risk of thigh bone fracture — postoperative periprosthetic femoral ...

Unpack the complexities of Section 524B, a key legislative directive aimed at fortifying cybersecurity measures within the ...

The company said the cuts to its global workforce are a “one-size right-sizing of the organization”. Edwards Lifesciences said it will lay off 3% of its global workforce in a “one-time right-sizing of ...

The increasing use of technology in medicine has created cybersecurity vulnerabilities that threaten healthcare systems and patient outcomes. Medical devices are particularly susceptible to attacks ...

As medical technology becomes more sophisticated and interconnected, device security threats escalate to pose risks in patient health and privacy. The U.S. FDA has strengthened its cybersecurity ...