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...

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.

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...

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.

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.

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.

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.

First, Do No Harm: Changing Strategies to Prove Your Medical Device Is Safe

Modern evaluation of biocompatibility uses a risk-based approach.

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 - Cybersecurity: Playbook for Threat Modeling Medical Devices

New best practices for understanding medical device security.

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.

The Three Challenges in Biomedical QC Testing

A robust, optimized mechanical testing program is essential to successful quality control testing.

Mastering the UKCA Compliance Challenge

Deadlines are approaching for compliance.

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.

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 - 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.

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.

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.

Is a Medical Robot Really a Robot?

There are no true "medical robots," says an industry expert. Here's why.

Can a Wearable Stop a Pandemic?

The COVID-19 pandemic has ushered in a new period of growth for wearables.

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: 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).

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.

New Products and Services

Magnetic angle sensors, heat-staking platforms, regulatory software, and more.

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.

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.

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...

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...

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."