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Standards and Compliance

The Risks of Optional Safety: Is Mandatory Safety Better?

This article discusses the legal and practical issues around the duty to design a safe product and how to decide whether various safety features that aren’t always necessary must be sold as standard features or whether they can be sold separately as options.

Cellular Approvals and RCM Certification in Australia

Compliance requirements for cellular devices that connect to the mobile phone networks in Australia are similar to those in other countries but with some important differences. In this article, we detail the unique aspects of ACMA technical regulations.

FDA Authorizes 50+ Testing Labs for Conformity Testing Pilot

The U.S. Food and Drug Administration (FDA) has now accredited more than 50 testing...

FDA Releases Catalog of Regulatory Science Tools for Medical Devices

To facilitate the expanded use of innovative science techniques in the development of new...

FDA Posts Biocompatibility Resource Center

The U.S. Food and Drug Administration (FDA) has collected a variety of resources to...
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Design Considerations in Spread Spectrum Modulation for CISPR 25/CE Testing

In this article, we establish design guidelines of a spread spectrum modulation circuit as it relates to CISPR 25.

MIL-STD-464D: A Review of Recent Changes

In this article, we detail the key changes between MIL-STD-464C and MIL-STD-464D, the recently-released update to the standard.

UK Passes Post-Brexit Medical Device Regulation

Moving to partially allay uncertainty regarding the approval of medical devices for use in...

FDA Modifies List of Recognized Standards for Medical Devices

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

FDA Provides Update on ASCA Testing Laboratory Accreditation

The U.S. Food and Drug Administration (FDA) says it will release within the next...
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