Windsor Agreement: Changes to Northern Ireland Regulatory Landscape

An agreement reached by the UK and EU regarding the Windsor Framework brings changes to the Northern Ireland regulatory landscape. The agreement , in principle, was reached...

Performance Review Institute Acquires SRI Quality System Registrar

The Performance Review Institute (PRI) has expanded its management systems certification portfolio through the acquisition of SRI Quality System Registrar. SRI is...

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.

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.

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.

New Products and Services

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

The Three Challenges in Biomedical QC Testing

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

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.

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 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.

New Products and Services

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

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...

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.

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.

A Fast, Simple Sampling Method for Characterizing Volatile Organic Compounds Emitted from Medical Devices

In 2018, an update on regulations for respiratory medical devices meant that volatile organic compounds (VOCs) emitted from the devices...

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...

Imaging System Helps Surgeons Remove Tiny Ovarian Tumors

Ovarian cancer is usually diagnosed only after it has reached an advanced stage, with many tumors spread throughout the abdomen. Most patients undergo surgery to remove as many of...

Luer Connectors: Testing to the New International Standard

The Luer connector is arguably one of the most important developments in the biomedical industry. Because it is reliable, simple to use, and economical to produce, the Luer connector...

Instron’s Calibration Laboratory Goes Global

As of September 2018, Instron’s Calibration Laboratory in Norwood, MA USA (NVLAP Lab Code 200301-0) expanded its global reach to include Europe into its existing operations. This...

Power Architectures for Patient-Connected Medical Devices

Meeting the requirements for patient-connected medical devices can present challenges for power system designers. There are several key elements to consider, including isolation,...

EMC for Medical Devices: EN/IEC 60601-1-2, 4th Edition

The fourth edition IEC/EN 60601-1-2 (4^th Edition) will become a mandatory standard covering safety for medical devices on December 31, 2018.^1,2 As with any new...

Reusable Medical Devices: BI Selection, Overkill Validation Approaches, and First-Time Validation Pass Rates in Common Healthcare Steam Sterilization Cycles

When validating the steam sterilization instructions for a reusable medical device,...