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Medical Devices

Medical Devices Increasingly Vulnerable to Cyberattacks

Despite ongoing publicity around the need to secure systems and equipment against the threat...

EU Commission Updates Biological Safety Standards Applicable under MDR

The Commission of the European Union (EU) has updated the list of standards that...

FDA Publishes Discussion Paper on 3D Printing of Medical Devices

The U.S. Food and Drug Administration (FDA) has released a discussion paper on the...

EU Commission Regulates Electronic Instructions for Medical Device Use

The Commission of the European Union (EU) has also published requirements for providing medical...

FDA Updates List of Recognized Standards for Medical Devices

The U.S. Food and Drug Administration (FDA) has updated its list of recognized international...
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EU Commission Sets Out Regulations for Medical Devices Database

The Commission of the European Union (EU) has issued its requirements for the medical...

FDA Publishes Principles for AI and ML in Medical Devices

Medical device regulatory agencies in the U.S., Canada, and the United Kingdom have recently...

EU Task Force Offers Clarification of Surveillance Requirements for Legacy Medical Devices

A European Union (EU) task force has issued a document intended to clarify the...

FDA Offers Best Practices for Alerting About Cyberthreats

As concerns about cybersecurity become part of the everyday threat landscape, the U.S. Food...

FDA Issues Draft Guidance on 510(k) Electronic Submission Template

The U.S. Food and Drug Administration (FDA) has issued a draft guidance to further...
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