Keyword: FDA Compliance/​Regulatory Affairs

Stories

Briefs: Regulations/Standards
AdvaMed: EPA’s EtO Proposals Create Significant Risk of a Healthcare Crisis
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
FDA Updates Catalog of Tools to Assess Medical Devices

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: Design
Summer 2023 Resource Guide
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
FDA Pilot Program Supports Streamlined Regulatory Submission Processes for Medical Device Manufacturers

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
Show Preview: Design of Medical Devices Conference 2023
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: Wearables
Movano Health to File First FDA Submission for Smart Ring’s SpO2 and Heart Rate Data

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: IoMT
Winter 2022 Resource Guide
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
Ensuring Regulatory Compliance by Digitizing Change Control in Life Sciences Product Development
Medical device manufacturers face constant changes coming from both internal and external sources.
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Supplements: Regulations/Standards
Summer 2022 Resource Guide
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
Exploring Valve Technology Requirements Under the New MDR
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: Regulations/Standards
First, Do No Harm: Changing Strategies to Prove Your Medical Device Is Safe
Modern evaluation of biocompatibility uses a risk-based approach.
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Features: Regulations/Standards
Establishing Proper Validation of Extruded Silicone Tubing
Bring your project from the process development phase of manufacturing to a fully validated one.
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From the Editor: Connectivity
From the Editor - Cybersecurity: Playbook for Threat Modeling Medical Devices
New best practices for understanding medical device security.
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Supplements: Sensors/Data Acquisition
Winter 2021 Resource Guide
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: Software
The Three Challenges in Biomedical QC Testing
A robust, optimized mechanical testing program is essential to successful quality control testing.
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Briefs: Medical
Mastering the UKCA Compliance Challenge
Deadlines are approaching for compliance.
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Features: Tubing & Extrusion
Inside Story: Watson-Marlow Fluid Technology Group
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: Mechanical & Fluid Systems
Summer 2021 Resource Guide
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: Medical
From the Editor - FDA Catalog of Tools Helps Accelerate Device Development
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
Show Preview: Evolving to MedDev 2021
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
Testing Strategies for EUA Devices
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
Is a Medical Robot Really a Robot?
There are no true "medical robots," says an industry expert. Here's why.
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Features: Medical
Can a Wearable Stop a Pandemic?
The COVID-19 pandemic has ushered in a new period of growth for wearables.
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Briefs: Regulations/Standards
PAs and NPs: How OEMs Can Reach This Critical Audience During the Pandemic
Regulatory changes have allowed these essential healthcare professionals to step in and help out more independently.
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From the Editor: AR/AI
From the Editor: A Look at FDA’s Plan for Artificial Intelligence and Machine Learning in Medical Devices
FDA just released the agency’s first action plan addressing artificial intelligence (AI) and machine learning (ML).
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Features: Medical
New Regulations, New Timelines: How Chemistry Changed in Response to ISO 10993-18:2020
Understand what part 18 of the 1099318 standard means for your product’s overall life cycle.
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Products: Regulations/Standards
New Products and Services
Magnetic angle sensors, heat-staking platforms, regulatory software, and more.
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From the Editor: Design
Guest Editorial - Medical Devices: LIFE after the EUA
When the Emergency Use Authorization Act is lifted, the FDA will have a real device review in place, says our guest editor.
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Applications: Manufacturing & Prototyping
Reimagining Knee Replacements with Additive Technology and Artificial Intelligence
To produce an additively manufactured prosthesis, REJOINT starts by 3D modelling the patient’s CT scan.
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Top Stories

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INSIDER: Medical

Ultrathin Nanotech Promises to Help Tackle Antibiotic Resistance

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Quiz: Medical

Medical Technology on the PGA Tour

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INSIDER: Medical

Breaking Barriers in Drug Delivery with Better Lipid Nanoparticles

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Features: Materials

Hydrogels as a Drug-Delivery Medium

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Features: Medical

Overcoming Blockers to Digitizing Manufacturing Operations

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INSIDER: Medical

Smart Pill Tracks Key Biomarkers in Real Time

Ask the Expert

Dan Sanchez on How to Improve Extruded Components
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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.

Webcasts

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Webinars: Medical

Scan-Based and Project Design for Medical

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Upcoming Webinars: Manufacturing & Prototyping

Precision, Control and Repeatability: Harnessing the Power of UV...

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Podcasts: Manufacturing & Prototyping

Here's an Idea: Medtech’s New Normal

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Podcasts: Materials

Here's an Idea: A Plant-Based Gel That Saves Lives

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Webinars: Medical

Adaptable Healthcare Solutions Designed for Safety and Security

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Podcasts: Medical

Here's an Idea: AI in MedTech

Inside Story

Rapid Precision Prototyping Program Speeds Medtech Product Development

Rapid prototyping technologies play an important role in supporting new product development (NPD) by companies that are working to bring novel and innovative products to market. But in advanced industries where products often make use of multiple technologies, and where meeting a part’s exacting tolerances is essential, speed without precision is rarely enough. In such advanced manufacturing—including the medical device and surgical robotics industries — the ability to produce high-precision prototypes early in the development cycle can be critical for meeting design expectations and bringing finished products to market efficiently.