Reported issues related to the device include two injuries and one death.
The company was accused of hiding serious health risks related to implantation of its transvaginal surgical mesh products.
Part three of this series discusses the key defenses available to each element of a lawsuit against providers and labs.
Operating with an antiquated QMS raises your risk. Here’s what to consider when modernizing your system.
As hackers target blind spots in wireless communications, medical devices running on various networks across the wireless spectrum pose big risks for healthcare facilities.
Don’t miss this opportunity to learn how your company can effectively push its product to the finish line.
It’s time for medtech design engineers to take a page from the enterprise security playbook.
The certifications recognize the company’s commitment to information security management and quality management systems.
The agency is recommending that patients replace their affected pumps with models that can better protect against the risks.
Domas to share her insights at the MedTech Intelligence Cybersecurity conference on September 26–27 in Cambridge, MA.