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.

Summer 2021 Resource Guide

Our 2021 Resource Guide shows you the top manufacturers in materials, manufacturing, and a range of other medical-device categories.

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.

Can a Wearable Stop a Pandemic?

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

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 Products and Services: December 2020 Medical Design Briefs

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...

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.

From the Editor - COVID-19 Ushers in New Technologies and a New Paradigm for the Medical Device Industry

FDA has issued multiple emergency use authorizations, loosened regulations for telemedicine, and eased the requirements for production...

FDA Creates New Program to Expedite Development of Coronavirus Treatments

The U.S. Food and Drug Administration (FDA) has established new program specifically geared toward expediting the development of potentially safe and effective...

From the Editor - FDA Launches eSTAR: Voluntary Electronic Submission Program for 510(k)s

FDA has kicked off a new voluntary electronic submission program for 510(k)s.

FDA Expedites Review of Diagnostic Tests to Combat COVID-19

The U.S. Food and Drug Administration (FDA) has made policy changes to respond to the urgent need for even faster testing availability. Although laboratories could use the EUA...

FDA Suspends Foreign and Domestic Inspections Due to Coronavirus

FDA is postponing most foreign and domestic inspections through April, effective immediately. Inspections outside the U.S. deemed mission-critical will still be considered on a...

From the Editor - Is FDA Making Progress or Still a Victim of Too Few Resources and Too Little Power?

FDA says it is continuing to advance its scientific and technical capabilities, but a recent New York Times editorial says the agency is in...

From the Editor — The Modern FDA: A New Pathway Gets Under Way

As a first step toward implementation of its recently established Safety and Performance Based Pathway for medical devices, FDA is issuing draft guidances outlining the...

From the Editor — Digital Health: Lessons Learned So Far from FDA’s Test Phase

The test phase of FDA’s Software Precertification (Pre-Cert) Program has hit its halfway point. The agency has released an update on its progress and the...

Industrial CT is Hip: Quality of Life Enhanced with Additive Manufacturing

Orthopedic devices play a crucial role in providing pain relief, improving mobility, and enhancing the quality of life for patients suffering from musculoskeletal...

Capturing Unique Device Identifier Data on Non-Sterile Orthopedic Implants

Now that medical devices are being labeled and uniquely identified to meet the requirements of the U.S. Food and Drug Administration (FDA) Unique Device Identifier...

Advanced Design Tools for Additively Manufactured Medical Devices

While the regulatory and validation burden can be high, it's not surprising that the medical device industry is one of the earliest adopters of additive manufacturing (AM, aka...

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...