Design & Testing

FDA/​Regulatory

Topics:

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.

Supplements: Manufacturing & Prototyping
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.
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.
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.
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.
From the Editor: Regulations/Standards
From the Editor - Cybersecurity: Playbook for Threat Modeling Medical Devices
New best practices for understanding medical device security.
Supplements: Regulations/Standards
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.
Features: Regulations/Standards
The Three Challenges in Biomedical QC Testing
A robust, optimized mechanical testing program is essential to successful quality control testing.
Products: Tubing & Extrusion
New Products and Services
Linear stepper stages, tubing, Bluetooth modules, and more.
Briefs: Design
Mastering the UKCA Compliance Challenge
Deadlines are approaching for compliance.
Features: Medical
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.
Supplements: Wearables
Summer 2021 Resource Guide
Our 2021 Resource Guide shows you the top manufacturers in materials, manufacturing, and a range of other medical-device categories.
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.
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.
Features: Test & Measurement
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.
Technology Leaders: Regulations/Standards
Is a Medical Robot Really a Robot?
There are no true "medical robots," says an industry expert. Here's why.
Features: Wearables
Can a Wearable Stop a Pandemic?
The COVID-19 pandemic has ushered in a new period of growth for wearables.
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.
From the Editor: Regulations/Standards
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).
Features: Regulations/Standards
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.
Briefs: Medical
Medical Device Usability Requirements: Changes to IEC 62366
The updated standard allows the manufacturer to assess and mitigate risks that are associated with correct use and use errors.
Products: Mechanical & Fluid Systems
New Products and Services
Magnetic angle sensors, heat-staking platforms, regulatory software, and more.
From the Editor: Regulations/Standards
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.
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.
Features: Medical
Are You Ready for the Next UDI Deadline?

As summer 2020 gives way to fall and we continue grappling with unprecedented challenges, healthcare industry efforts persist to ensure that medical supplies are available when and where they are...

Blog: Medical
Medical Devices: LIFE after the EUA

Yes, there will be a day when the U.S. EUA, Emergency Use Authorization Act, will be lifted, the medical device industry goes back to reality, and the FDA regains control of the medical approval process...

Features: Regulations/Standards
EU MDR Economic Operators: Sharing Compliance Duties across the Supply Chain
A number of manufacturers are still in the process of confirming who qualifies as an "Economic Operator."
Products: Materials
New Products and Services
Conduits, heat sinks, bioadhesives, and more.
Blog: Regulations/Standards
FDA Teams Up with Aetion to Analyze Real-World COVID-19 Data

In an effort to harness diverse streams of data to understand and respond to COVID-19, the U.S. Food and Drug Administration (FDA) has entered into an agreement with Aetionto...

Features: Design
Q&A: How Do You Protect Your IP?
Philip Nelson, a partner with Knobbe Martens, provides some insights for device companies facing challenges with intellectual property.

Top Stories

Products: Imaging

New Products and Services

INSIDER: Nanotechnology

Smart Mask Tracks Respiratory Sounds to Identify Disease

Features: Medical

2022 Medical Winner: The Novel Squid Glaucoma MicroShunt

INSIDER: Wearables

SkinKit: Versatile, Wearable On-Skin Computing

INSIDER: Internet of Things

Consortium to Advance Digital Twins in Healthcare

Features: Medical

Inside the OEM: Stryker

Ask the Expert

John Chandler on Achieving Quality Motion Control

FAULHABER MICROMO brings together the highest quality motion technologies and value-added services, together with global engineering, sourcing, and manufacturing, to deliver top quality micro motion solutions. With 34 years’ experience, John Chandler injects a key engineering perspective into all new projects and enjoys working closely with OEM customers to bring exciting new technologies to market.

Webcasts

Webinars: Medical

Developing the Ultimate Medical Sensor Technology

Webinars: Medical

Precision Pulsed High Voltage: Electroporation Enabling Medical and Life...

On-Demand Webinars: Manufacturing & Prototyping

Product Development Lifecycle Management: Optimizing Quality, Cost, and Speed...

Webinars: Medical

Medical Device Biofilms: Slimy, Sticky, Stubborn, and Serious

On-Demand Webinars: Medical

Artificial Intelligence and Machine Learning: Making Medical Devices Smarter

On-Demand Webinars: Materials

Specialized Coatings for Advanced Medical Devices

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.

Trending Stories

News: Medical

Keynote: The Future of Healthcare Is Happening Now

Briefs: Wearables

Tiny, Wireless, Injectable Chips Use Ultrasound to Monitor Body Processes

Videos