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Standards and Compliance

How Do You Compare ANSI/ESD S20.20 and MIL-STD-1686?

Confusion is created when there is more than one standard to define requirements. For ESD control, this has been the case with a military standard (MIL‑STD‑1686) and ANSI/ESD S20.20.

Australian Radio Communications, EMC and EMF Regulatory Requirements: A Primer

Wireless devices are now in the legislative spotlight the world over. Safety, performance, spectrum usage and protection of personal data are all matters of regulation, although countries vary in how they regulate such concerns. This article looks at Australia as a case study, reviewing the overarching legal framework, the role of the national regulator, conformity assessment and the use of standards.

U.S. FCC Grants Healthcare Waiver to Expedite Medical Equipment

In the midst of the COVID-19 pandemic, the U.S. Federal Communications Commission (FCC) has...

EUs MDR Date of Application Delayed Until 2021

In a major development for medical device manufacturers, the Parliament and Council of the European...

The Risk of Post-Sale Safety Improvements

This article presents the legal issues around pre- and post-sale safety improvements in products and provides recommendations to document them.
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U.S. FDA Temporarily Eases Enforcement Policies for Certain Digital Health Devices

Moving quickly to address the need for advanced medical technologies during the COVID-19 outbreak...

The Making of an ISO 7010 Symbol

Understanding the Process to Create Standardized Symbols and How It Effects Your On-product Warnings The...

Standards Development Process

The standards development and revision process can appear to be a lot like consulting some hallowed oracle with edicts or directives that cannot be questioned.

Contracts That Help or Hurt

When it comes to contracts, what terms and conditions are most important, and how can engineers support their company’s efforts to evaluate and minimize risks?

FDA Updates Database of Recognized Consensus Standards for Medical Devices

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