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.

New Products and Services: December 2021 Medical Design Briefs

Linear stepper stages, tubing, Bluetooth modules, and more.

Mastering the UKCA Compliance Challenge

Deadlines are approaching for compliance.

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.

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.

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.

Is a Medical Robot Really a Robot?

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

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).

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."

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.

Class I Manufacturers: 8 Steps to Tackle EU MDR Compliance

Why Class I manufacturers should not place European Medical Device Regulation (EU MDR) compliance at the end of their to-do lists.

Your MDR Strategy: Start with a Gap Analysis

How to make sense of the 566-page Medical Device Regulation (MDR). This article focuses on a strategy to address material information and what should be included in a gap analysis.

FDA Issues Emergency Use Authorization for Ventilators

The U.S. Food and Drug Administration (FDA) took action May 25, 2020, to make more ventilators available to healthcare personnel in the United States. FDA issued an emergency use...

COVID-19: FDA Continues to Facilitate Access to Crucial Medical Products, Including Ventilators

The U.S. Food and Drug Administration took significant action to help increase the availability of ventilators and accessories, as well as other...

FDA Adds More Dates for Town Halls for COVID-19 Test Developers

On Wednesday, March 25, 2020 (3–4 p.m. Eastern), the U.S. Food and Drug Administration (FDA) will host a virtual Town Hall for clinical laboratories and commercial...

COVID-19: FDA Expands Remote Patient Monitoring

The Food and Drug Administration (FDA) has issued a new guidance to provide a policy to help expand the availability and capability of noninvasive remote monitoring devices to facilitate...

COVID-19: FDA Issues Diagnostic Emergency Use Authorization; Expedites Availability of Diagnostics

The U.S. Food and Drug Administration (FDA) has taken two additional significant diagnostic actions during the coronavirus outbreak (COVID-19)...

From the Editor — Most Medical Device OEMs Not Ready to Comply with 2020 EU Regulation

Under new rules to market medical devices in the European Union (EU), only 27 percent of respondents said they will be fully compliant with the...

Why Cloud QMS Better Supports Regulatory Compliance

Companies regulated by the U.S. Food and Drug administration (FDA) need to establish current good manufacturing practices (CGMPs) as part of Title 21 CFR part 820 requirements. This...

From the Editor — Spurring Innovation of Brain-Computer Interface Devices

Spurring Innovation of Brain-Computer Interface Devices FDA is continuing to encourage innovation in novel areas — the latest being novel brain implants, often...

Guide to FDA Requirements and Importance of Medical Device Calibration

Calibration of a device is carried out to minimize the uncertainty in measurements. It helps in reducing the errors and brings the measurement to an acceptable level....