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.

Latest Briefs & News

The updated standard allows the manufacturer to assess and mitigate risks that are associated with correct use and use errors.
Magnetic angle sensors, heat-staking platforms, regulatory software, and more.
Features: FDA/Regulatory
Q&A: How Do You Protect Your IP?
Philip Nelson, a partner with Knobbe Martens, provides some insights for device companies facing challenges with intellectual property.

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

Features: Test & Measurement
Your MDR Strategy: Start with a Gap Analysis
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.
Why Class I manufacturers should not place European Medical Device Regulation (EU MDR) compliance at the end of their to-do lists.

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

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

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...

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...

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...

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

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...

When validating the steam sterilization instructions for a reusable medical device,...

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...

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: Medical
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...

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: FDA/Regulatory
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: Test & Measurement
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.

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...

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

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...

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

The Internet of Things (IoT) has been described as the interconnection via the Internet of computing devices embedded in everyday objects, enabling them to send and...

Electromagnetic compatibility (EMC) requirements for medical devices and systems is defined by IEC 60601-1-2. The fourth edition implementation of this EMC...

News: FDA/Regulatory
FDA Touts New AAMI Report on ‘Wireless Coexistence’ and Medical Devices

The Food and Drug Administration (FDA) is flagging a new technical information report (TIR) from AAMI that provides crucial guidance for “wireless coexistence” for a wide array of medical devices and systems.

Safety and reliability are the key concerns when determining the right power source for a medical device. Lithium-ion (Li-ion) batteries are often considered for their higher...

Design validation is one of the most important aspects of the design and development process for medical devices. It is at this stage that the medical device manufacturer confirms that the device...

Ask the Expert

Dan Sanchez on How to Improve Extruded Components

Improving extruded components requires careful attention to a number of factors, including dimensional tolerance, material selection, and processing. Trelleborg’s Dan Sanchez provides detailed insights into each of these considerations to help you advance your device innovations while reducing costs and speeding time to market.

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