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

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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: Materials
Written by Katie Falcone, Scientific Support Manager, Datwyler, this article addresses the dangerous implications of micro material contamination.
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Briefs: Medical
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: Medical
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: Medical

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: Physical Sciences

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: Manufacturing & Prototyping
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: Physical Sciences

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

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Trivia: Regulations/Standards

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

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Trivia: Medical

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: Test & Measurement
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: Materials
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: Connectivity
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: Regulations/Standards
Linear stepper stages, tubing, Bluetooth modules, and more.
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Features: Regulations/Standards
A robust, optimized mechanical testing program is essential to successful quality control testing.
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Supplements: Tubing & Extrusion
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: Automotive
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: Test & Measurement
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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Briefs: Medical
The updated standard allows the manufacturer to assess and mitigate risks that are associated with correct use and use errors.
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Products: Medical
Magnetic angle sensors, heat-staking platforms, regulatory software, and more.
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Features: Regulations/Standards
Philip Nelson, a partner with Knobbe Martens, provides some insights for device companies facing challenges with intellectual property.
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From the Editor: Regulations/Standards

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

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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: Developing a Package Performance Testing Plan
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To find out more about the expertise required to develop a testing plan for package performance testing, MDB recently spoke with Sunny Modi, Director of Package Testing for Eurofins Medical Device Testing in Lancaster, PA.

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