Standards and Compliance

Stay informed with standards updates, explore standards insights by topic, understand the importance of product liability, and learn international compliance best practices to ensure your products meet global regulatory requirements effectively.

How Manufacturers and Retailers Can Collaborate to Provide Quality Products and Conduct Effective Recalls

Manufacturers, retailers, and regulators have been working to improve product safety and make recalls more effective. This has been especially important for online retailers who have additional ways to directly contact their customers.

EU Commission Proposes More Time for Compliance with IVDR

The Commission of the European Union (EU) has proposed providing manufacturers of certain medical...

FDA Adds Vaporized Hydrogen Peroxide as Established Sterilization Method for Medical Devices

The U.S. Food and Drug Administration (FDA) has recently authorized the use of vaporized hydrogen peroxide (H2O2) as an established sterilization method for medical devices.

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...

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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...

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The U.S. Food and Drug Administration (FDA) has recently issued two draft guidance documents...

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Standards and Compliance

International Product Compliance

Major Standards Organizations

American National Standards Institute (ANSI)

European Committee for Electrotechnical Standardization (CENELEC)

Institute of Electrical and Electronics Engineers (IEEE)

International Electrotechnical Commission (IEC)

International Organization for Standardization (ISO)

International Special Committee on Radio Interference (CISPR)

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What's New

Soft Disciplines

FCC Warns of Spoofed Mortgage Provider Calls from “Green Mirage”

FCC Issues its PIRATE Radio Annual Report

High Intensity Radiated Fields (HIRF), Part 2

FDA Issues Draft Guidance on AI-Based Medical Devices