FDA/​Regulatory

Standards & Standards Development

Want to learn more about ISO 13485, IEC 62304, ISO 62304, and other medical device standards? Get expert advice and news about the latest procedural regulations surrounding healthcare.

Supplements: AR/AI
Our 2021 Resource Guide shows you the top manufacturers in materials, manufacturing, and a range of other medical-device categories.
From the Editor: FDA/Regulatory
FDA has created a “Catalog of Regulatory Science Tools,” in which it provides a comprehensive list of peer-reviewed resources for medical device developers.
Features: Design
The "Evolving To MedDev" 2021 digital event will provide automotive and aerospace companies with practical information about how they can enter into the medical device supply chain.
Features: FDA/Regulatory
While many devices have received Emergency Use Authorization (EUA) for short-term use, new testing procedures are needed for the long-term.
From the Editor: FDA/Regulatory
FDA just released the agency’s first action plan addressing artificial intelligence (AI) and machine learning (ML).
Briefs: Medical
The updated standard allows the manufacturer to assess and mitigate risks that are associated with correct use and use errors.
Products: Mechanical & Fluid Systems
Magnetic angle sensors, heat-staking platforms, regulatory software, and more.
Features: Design
Philip Nelson, a partner with Knobbe Martens, provides some insights for device companies facing challenges with intellectual property.
From the Editor: FDA/Regulatory

FDA has issued multiple emergency use authorizations, loosened regulations for telemedicine, and eased the requirements for production...

Features: FDA/Regulatory
How to make sense of the 566-page Medical Device Regulation (MDR). This article focuses on a strategy to address material information and what should be included in a gap analysis.
Features: Medical
Why Class I manufacturers should not place European Medical Device Regulation (EU MDR) compliance at the end of their to-do lists.
Briefs: Medical

In 2018, an update on regulations for respiratory medical devices meant that volatile organic compounds (VOCs) emitted from the devices...

Features: Manufacturing & Prototyping

Orthopedic devices play a crucial role in providing pain relief, improving mobility, and enhancing the quality of life for patients suffering from musculoskeletal...

Briefs: Medical

Ovarian cancer is usually diagnosed only after it has reached an advanced stage, with many tumors spread throughout the abdomen. Most patients undergo surgery to remove as many of...

Features: FDA/Regulatory

The Luer connector is arguably one of the most important developments in the biomedical industry. Because it is reliable, simple to use, and economical to produce, the Luer connector...

News: Test & Measurement

As of September 2018, Instron’s Calibration Laboratory in Norwood, MA USA (NVLAP Lab Code 200301-0) expanded its global reach to include Europe into its existing operations. This...

Features: Medical

Meeting the requirements for patient-connected medical devices can present challenges for power system designers. There are several key elements to consider, including isolation,...

Features: Test & Measurement

The fourth edition IEC/EN 60601-1-2 (4th Edition) will become a mandatory standard covering safety for medical devices on December 31, 2018.1,2 As with any new...

Features: Test & Measurement
INSIDER: FDA/Regulatory

A grant from the National Institute of Standards and Technology (NIST) will be used to to develop standards for regenerative medicine and biomaterial manufacturing. NIST...

Features: Medical

A key driver of the medical disposables market is the desire to minimize the risk of healthcare-associated infections (HAIs). Healthcare providers are turning to disposable...

News: Test & Measurement
Medical Device Preclinical Bootcamp to Explore Testing Pathway

An upcoming seminar will explore the preclinical testing pathway for medical devices. The event will cover everything from concept to regulatory submission, including relevant regulations and standards, as well as the role each type of test plays in the overall testing program. It...

Features: FDA/Regulatory

In an industry where people's health and wellness are on the line, manufacturers can't afford to let risk go unaddressed. As the International Organization for...

News: Medical
New Exoskeletons and Exosuits Standards Group Outlines First Steps

ASTM International’s new committee on exoskeletons and exosuits (F48) held its first meeting Feb. 13–14 in Philadelphia, PA, near the organization’s global headquarters. The need for technical standards has grown alongside the rising use of exoskeletons in manufacturing,...

News: Medical
Biocompatibility Expert to Discuss Successful Sample Preparation for Medical Device Testing

Properly prepared test articles are critical for accurate biocompatibility testing. As a sponsor of a medical device, it is imperative for medical device manufacturers to understand what to do to ensure a successful test of a proposed medical device.

Features: FDA/Regulatory

When ISO 9001 was produced by the International Standards Organization, it put forth the general quality standard that organizations could adopt to ensure that the organization is focused on...

Technology Leaders: FDA/Regulatory

Traditionally, toxicologists and biocompatibility experts considered the materials in breathing gas pathways as external communicating devices and evaluated...

Features: Medical

The reliability of the embedded software used in medical devices and the risk associated with it has become a vital concern. IEC 62304, “Medical device...

Features: Software

FDA’s introduction to its rules for medical device regulation states: “Medical devices are classified into Class I, II, and III. Regulatory control...

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Eric Dietsch on the Benefits of Nitinol Wire

In collaboration with the Fort Wayne Metals Engineering team, Eric Dietsch focuses on supporting customers with material recommendations, product development, and education. Eric is available to help you and your company with any Nitinol-related questions or needs that you may have.

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