Keyword: FDA Compliance/​Regulatory Affairs

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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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

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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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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Briefs: Regulations/Standards
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 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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Supplements: Robotics, Automation & Control
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: Medical

The current U.S. regulatory framework for medical devices under the Center for Devices and Radiological Health (CDRH) includes extensive...

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Features: Design
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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News: Regulations/Standards

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: Tubing & Extrusion
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: Government
Medical device manufacturers face constant changes coming from both internal and external sources.
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Supplements: Materials
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: Mechanical & Fluid Systems
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: 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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Features: Manufacturing & Prototyping
A robust, optimized mechanical testing program is essential to successful quality control testing.
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Briefs: Regulations/Standards
Deadlines are approaching for compliance.
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Features: Regulations/Standards
Rodd Turnquist tells Medical Design Briefs how to select the best pumps for medical devices and accelerating time to market.
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Supplements: Manufacturing & Prototyping
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: Regulations/Standards
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: Manufacturing & Prototyping
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: Regulations/Standards
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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Technology Leaders: Robotics, Automation & Control
There are no true "medical robots," says an industry expert. Here's why.
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Features: Regulations/Standards
The COVID-19 pandemic has ushered in a new period of growth for wearables.
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Briefs: Regulations/Standards
Regulatory changes have allowed these essential healthcare professionals to step in and help out more independently.
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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: Ensuring Reusable Devices Are Safe for the Next Patient
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To find out more about the expertise required to establish safe processes for cleaning and disinfecting reusable medical devices, MDB recently spoke with Elizabeth Sydnor, Director of Microbiology Medical Device Testing, Eurofins Medical Device Testing (Lancaster, PA).

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