Keyword: Standards and 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.

Stories

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INSIDER: Regulations/Standards

On Tuesday, February 6 at 12:30 pm, Balazs Boznik, BSEE, Technical Director, Medical Audit, at SGS North America will discuss FDA’s plan to adopt ISO 13485.

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Features: Connectivity
ISO 80369 Part 7, the long-awaited replacement to ISO 594, introduced a number of changes to the standard governing dimensions and performance requirements of Luer connectors.
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From the Editor: Regulations/Standards
Analytics firm GlobalData has weighed in on the U.S. FDA's proposal to reclassify laboratory-developed tests (LDTs) as medical devices. FDA historically exercised enforcement discretion over LDTs, meaning that it did not actively regulate them like it does for other medical devices, so this is a significant regulatory change.
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News: Regulations/Standards

NuVasive and Zimmer Biomet, both leading innovators in the medical devices industry, have become Pending Subscribers to the MedAccred accreditation program.

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Briefs: Medical
Neither the MDR nor Annex XVI are new. Nevertheless, the entry into force of the common specifications now presents a new situation for manufacturers of devices without an intended medical purpose.
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From the Editor: Medical
Written by Katie Falcone, Scientific Support Manager, Datwyler, this article addresses the dangerous implications of micro material contamination.
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Briefs: Packaging & Sterilization
The EPA issued two separate proposals earlier this year covering the use of EtO for device sterilization: the National Emission Standards for Hazardous Air Pollutants and the preliminary interim decision under the Federal Insecticide, Fungicide, and Rodenticide Act.
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News: Regulations/Standards

The Performance Review Institute (PRI) has launched a new service designed to help companies improve manufacturing and quality management and improve...

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News: Regulations/Standards

TÜV SÜD has received approval as a UK Approved Body (UKAB) for medical devices. With this approval, medical device manufacturers can implement UKCA certification for the UK market and...

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Briefs: Regulations/Standards
Thanks to artificial intelligence (AI), augmented reality (AR) has long shaped product development across a variety of areas, including the medtech industry.
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News: Regulations/Standards

An agreement reached by the UK and EU regarding the Windsor Framework brings changes to the Northern Ireland regulatory landscape. The agreement , in principle, was reached...

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News: Regulations/Standards

The Performance Review Institute (PRI) has expanded its management systems certification portfolio through the acquisition of SRI Quality System Registrar. SRI is...

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Trivia: Medical

It's March Madness! What organization was founded by a small group of physical educators and physicians who recognized that health problems were associated with certain lifestyle choices, especially smoking and lack of...

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Supplements: Connectivity
In our summer edition of the MDB Resource Guide, learn about new cleaning requirements and find the right company to match your medical-design needs.
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Trivia: Medical

In November 1848, what was the first medical school to open for women?

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Trivia: Physical Sciences

In July 1965, what landmark amendment was passed that helped drive medical innovation and improve the quality of healthcare?

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Trivia: Transportation

At the turn of the 19th century, what industry was so dangerous that surgeons became specially trained to address the unique injuries of its employees?

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Supplements: Mechanical & Fluid Systems
In our summer edition of the MDB Resource Guide, learn about new cleaning requirements and find the right company to match your medical-design needs.
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Technology Leaders: Regulations/Standards
Modern evaluation of biocompatibility uses a risk-based approach.
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Features: Regulations/Standards
Bring your project from the process development phase of manufacturing to a fully validated one.
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From the Editor: Regulations/Standards
New best practices for understanding medical device security.
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Supplements: Test & Measurement
In our winter edition of the MDB Resource Guide, learn about new cleaning requirements and find the right company to match your medical-design needs.
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Products: Materials
Linear stepper stages, tubing, Bluetooth modules, and more.
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Features: Medical
A robust, optimized mechanical testing program is essential to successful quality control testing.
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Supplements: Mechanical & Fluid Systems
Our 2021 Resource Guide shows you the top manufacturers in materials, manufacturing, and a range of other medical-device categories.
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From the Editor: Design
FDA has created a “Catalog of Regulatory Science Tools,” in which it provides a comprehensive list of peer-reviewed resources for medical device developers.
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Features: Regulations/Standards
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.
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Features: Medical
While many devices have received Emergency Use Authorization (EUA) for short-term use, new testing procedures are needed for the long-term.
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From the Editor: Medical
FDA just released the agency’s first action plan addressing artificial intelligence (AI) and machine learning (ML).
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Ask the Expert

Ralph Bright on the Power of Power Cords
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Understanding power system components and how to connect them correctly is critical to meeting regulatory requirements and designing successful electrical products for worldwide markets. Interpower’s Ralph Bright defines these requirements and explains how to know which cord to select for your application.

Inside Story

Inside Story: Validating Your Sterilization Process
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To find out more about sterile product development and registration, MDB recently spoke with Elizabeth Sydnor, Director of Microbiology of Eurofins Medical Device Testing (Lancaster, PA). Read the interview.

Videos