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Standards and Compliance

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FDA Issues Draft Guidance on 510(k) Electronic Submission Template

The U.S. Food and Drug Administration (FDA) has issued a draft guidance to further...

FDA Publishes List of Approved AI/ML-Enabled Medical Devices

The U.S. Food and Drug Administration (FDA) has published its first list of authorized...

UK Seeks Overhaul of AI, Software as a Medical Device

In the wake of its exit from the European Union, the United Kingdom is...

EU Commission Updates List of Harmonized Standards for MDR

The Commission of the European Union (EU) has updated its list of harmonized standards...
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FDA Offers Online Tracker for Premarket Submissions

The U.S. Food and Drug Administration (FDA) now has a secure web-based tracking system...

Toward Standardization of Low Impedance Contact CDM

The 16.6 ohm implementation of contact CDM (LICCDM) recently published in ANSI-ESD Standard Practice 5.3.3 is shown to produce waveforms of similar shape, Ifail, and Ipeak vs. Ceff dependency as JS-002. The non-monotonicity of JS-002 at low voltages is overcome using LICCDM. A path to joint standardization with air discharge testing is proposed.

FDA Releases Discussion Paper on Medical Device Cybersecurity Challenges

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

FDA Extends Comment Period on Remanufacturing of Medical Devices Guidance

The U.S. Food and Drug Administration (FDA) has extended the public comment period on...

The Effect of Standards on Safety and Product Liability Litigation

This article will discuss the basic kinds of defects that can be alleged in any product liability case, the law as it pertains to compliance with standards, and some tips on how to deal with the issue of standards compliance.
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