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Standards and Compliance

NIST Extends Deadline for Comments on Strategy for Critical and Emerging Technology

The U.S. Department of Commerce’s National Institute of Standards and Technology (NIST) has extended...

MedTech Europe Offers Its Vision for the Future of MedTech Regulations

A consortium of medical technology companies in the European Union (EU) has published a...

FDA Issues Guidance on Electronic Submissions of 510(k)s

The U.S. Food and Drug Administration (FDA) has released its final guidance on premarket...

FDA Issues Final Guidance on Testing/Labeling of Medical Devices in MR Environments

The U.S. Food and Drug Administration (FDA) has released the final version of its...

FDA Issues Guidance on Medical Device Cybersecurity Quality System Considerations

The U.S. Food and Drug Administration (FDA) has released its Final Guidance on cybersecurity...
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FDA Issues Final Guidance on ISO 10993-1 for Biological Evaluation of Medical Devices

The U.S. Food and Drug Administration (FDA) has issued a final guidance document on...

FDA Issues Draft Guidances on Clinical Data, Predicate Devices in Premarket Notifications

The U.S. Food and Drug Administration (FDA) has recently issued two draft guidance documents...

NIST Releases Cybersecurity Framework 2.0 Draft

The National Institute of Standards and Technology (NIST) has recently published for public comment...

FDA Updates List of Recognized Standards

The U.S. Food and Drug Administration (FDA) has updated its list of recognized international...

The Legal Perils of Customer Service

Customer service, before and after sale, is one of the most important functions that must be performed by a manufacturer or product seller. It is also one of the riskiest. Obtaining no information, inadequate information, wrong information, misleading information, or harmful information can make it difficult to evaluate future risk, meet your regulatory obligations, and defend a product liability lawsuit.
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