Design & Testing

FDA/​Regulatory

Learn about FDA medical device regulations and how to achieve approval. Our news and expert advice provides an overview of regulatory requirements for Class I, Class II, and Class III devices.

 Features : FDA/Regulatory
Safety, Compliance, and Regulation: The Gateway for Laser-Based Products into the Marketplace

Many medical devices, both existing and new designs, are laser-based. For some time, lasers have been designed into medical devices from diagnostic, imaging, and therapeutic systems, to invasive treatment designs like those for cauterization, surgical...

 News : Medical
FDA Issues Small Entity Compliance Guidance for UDI

On August 13, The FDA issued a guidance for industry and FDA staff called “Unique Device Identification System: Small Entity Compliance Guide”. This guidance is intended primarily to provide information to the medical device industry, including small businesses, concerning FDA’s...

 News : FDA/Regulatory
New Proposed ASTM Standard

ASTM International, formerly known as the American Society for Testing and Materials (ASTM), West Conshohocken, PA, has proposed a new international standard to be used in the design, development, quality control, and comparison of a variety of collagen-based medical products, including surgical implants, delivery...

 News : FDA/Regulatory
FDA Finalizes Rule on UDI

Today, the FDA issued its final rule on the unique device identification (UDI) system that, once implemented, will provide a consistent way to identify medical devices. The UDI system should improve the quality of information in medical device adverse events reports, which will help the FDA identify product problems...

 News : FDA/Regulatory
FDA Issues Guidance on Wireless Technology in Medical Devices

The FDA Center for Devices and Radiological Health, Office of Science and Engineering Laboratories, Center for Biologics Evaluation and Research issued a Guidance document on “Radio Frequency Wireless Technology in Medical Devices” containing recommendations to assist industry and...

 Features : Medical
Endotoxin Testing: FDA Update Prompts Time for Review

The recent publication by the U.S. Food and Drug Administration (FDA) of Guidance for Industry Pyrogen and Endotoxins Testing: Questions and Answers, dated June of 2012, the Department of Health and Human Services updated the agency’s thinking regarding pyrogen and bacterial endotoxin...

 Features : FDA/Regulatory
Quality Management: Key To Medical Electronics Assembly and Manufacturing

No other industry in the US is under more pressure than medical electronics, and those pressures continue mounting each year for greater innovation and products that are faster, better, at lower cost, and in total compliance with regulatory standards. Those standards are...

 News : Markets
Singapore Eases Market Entry for Lower-Risk Devices

Singapore's Health Sciences Authority (HSA), the country’s medical device market regulator, has implemented new rules in order to expedite market access for lower-risk medical devices.

The rules will exempt all Class A medical devices (except sterile Class A products) from HSA...

 Features : FDA/Regulatory
The Automation of FDA Medical Device Design Controls

Every medical device company faces the challenge of navigating through the FDA’s mandatory regulations, and companies have different needs that change as they mature. Early-stage medical device companies provide the innovation and intellectual property that feed the medical device industry...

 Features : FDA/Regulatory
What’s So Hard About Medical Device Software Compliance?

The IEC 62304 standard for medical device software is causing system engineers worldwide to step back and examine their software development methods with considerable scrutiny. Although at one time, software development and testing was an integral part of overall system design and...

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