Design & Testing

FDA/​Regulatory

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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.

Latest Briefs & News

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News: Medical

MasterControl, a provider of quality and manufacturing software solutions for the life sciences industry, has released a new study analyzing five years of product recall...

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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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Blog: Manufacturing & Prototyping
Understanding what the FDA really means by their time frames, knowing how to address their regulatory issues, and preparing a response to a 483 or Warning Letter is critical to showing the FDA that you understand what they expect from you and that you will work to bring your company into compliance. Another critical point is to understand that you can negotiate with the agency.
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News: Medical

The U.S. Food and Drug Administration has created a new Digital Health Advisory Committee to help the agency explore the complex, scientific and technical issues...

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News: Design

To foster the development and commercialization of medical devices designed for children, the Food and Drug Administration (FDA) has awarded a nearly $7.5 million grant to...

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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: 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: Medical

Organ transplant developer, Paragonix Technologies has received FDA clearance for its next-generation donor lung preservation system,...

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News: Manufacturing & Prototyping

The U.S. Food and Drug Administration (FDA) updated its Catalog of Regulatory Science Tools by adding four new tools and updating nine others. The catalog is a peer-reviewed...

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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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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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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: Manufacturing & Prototyping

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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Features: Medical
The Institute for Engineering in Medicine’s Innovation Week highlights events that focus on advances and new directions in medical engineering.
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Trivia: Regulations/Standards

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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News: Wearables

Movano Health, Pleasanton, CA, has announced successful preliminary results of its pivotal hypoxia trial, which was completed in conjunction with the...

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Supplements: Sensors/Data Acquisition
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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Features: Software
Medical device manufacturers face constant changes coming from both internal and external sources.
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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: 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: Regulations/Standards
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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Features: Regulations/Standards
Although the pandemic has delayed the MDR’s validation date, it has not diminished the importance of this new regulation.
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Technology Leaders: Medical
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: Medical
New best practices for understanding medical device security.
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Ask the Expert

Eric Dietsch on the Benefits of Nitinol Wire
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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.

Inside Story

Inside Story: Selecting the Best Pump for Your Medical Device
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MDB spoke to Rodd Turnquist, National Sales Manager US, OEM Division, WMFTS, to find out more about selecting the best pumps for medical devices and accelerating time to market.

Videos