Proposed Surgical Devices Standard Covers Properties for Nickel Titanium Alloy

ASTM International’s medical and surgical devices committee (F04) is developing a proposed standard for a wrought nickel-titanium alloy. The alloy covered by the...

From Manufacturing to Medicine: A Shared Mission

Through collaboration SAE International, Performance Review Institute (PRI) and Medical Design Briefs (MDB) extend their knowledge throughout the life sciences industry, driving innovation in...

From the Editor - Bipartisan Legislation Could Fast-Track Breakthrough Medical Devices

The U.S. Senate's bipartisan legislation to expedite Medicare coverage of FDA-breakthrough-designated medical technologies and diagnostic tests could significantly impact the medical device industry and manufacturers, streamlining processes for breakthrough devices, enhancing patient access, and reducing barriers to market entry. Read on to see what Sherrie Trigg, Editor and Director of Medical Content, thinks about the matter.

Children’s National, FDA Collaborate to Advance Pediatric Device Regulatory Tools

In a significant collaboration to help advance pediatric health, Children’s National Hospital and the U.S. Food and Drug Administration’s (FDA) Office of...

From the Editor - FDA’s Final Rule on LDTs Raises Concerns for Personalized Medicine

Hear directly from Sherrie Trigg, Editor and Director of Medical Content, about the FDA's final ruling on LDTs and why that is raising concern.

Why Standardization Matters in Pulsed Electric Field Generation for Clinical Electroporation

Pulsed field ablation is a nonthermal method of tissue ablation technology that uses high amplitude pulsed electrical fields to create irreversible electroporation in tissues. Read on to learn more about it.

A Look at Vaporized Hydrogen Peroxide as a Sterilization Option

The changing regulatory landscape and innovation of medical products is driving an interest in additional options for medical product sterilization. Read on to learn what this means.

ANSI/AAMI ST24 Updated to Reflect Technological Changes

As leaders in the medical device industry seek ways to optimize the application of ethylene oxide (EO) sterilization, it is more important than ever to ensure that medical device...

Medtech Theater: U.S. Food and Drug Administration to Adopt ISO 13485

On Tuesday, February 6 at 12:30 pm, Balazs Boznik, BSEE, Technical Director, Medical Audit, at SGS North America will discuss FDA’s plan to adopt ISO 13485.

ISO 80369-7: Changing the Standard for Luer Connectors

ISO 80369 Part 7, the long-awaited replacement to ISO 594, introduced a number of changes to the standard governing dimensions and performance requirements of Luer connectors.

From the Editor - FDA's LDT Regulation Must Balance Safety and Innovation

Analytics firm GlobalData has weighed in on the U.S. FDA's proposal to reclassify laboratory-developed tests (LDTs) as medical devices. FDA historically exercised enforcement discretion over LDTs, meaning that it did not actively regulate them like it does for other medical devices, so this is a significant regulatory change.

MedAccred: NuVasive, Zimmer Biomet Become Pending Members

NuVasive and Zimmer Biomet, both leading innovators in the medical devices industry, have become Pending Subscribers to the MedAccred accreditation program.

MDR: Regulating Devices That Don’t Have an Intended Medical Purpose

Neither the MDR nor Annex XVI are new. Nevertheless, the entry into force of the common specifications now presents a new situation for manufacturers of devices without an intended medical purpose.

Guest Editorial

Written by Katie Falcone, Scientific Support Manager, Datwyler, this article addresses the dangerous implications of micro material contamination.

AdvaMed: EPA’s EtO Proposals Create Significant Risk of a Healthcare Crisis

The EPA issued two separate proposals earlier this year covering the use of EtO for device sterilization: the National Emission Standards for Hazardous Air Pollutants and the preliminary interim decision under the Federal Insecticide, Fungicide, and Rodenticide Act.

PRI Launches New Program to Help Companies Improve Manufacturing, Quality

The Performance Review Institute (PRI) has launched a new service designed to help companies improve manufacturing and quality management and improve business...

TÜV SÜD Receives UKAB for Medical Devices

TÜV SÜD has received approval as a UK Approved Body (UKAB) for medical devices. With this approval, medical device manufacturers can implement UKCA certification for the UK market and CE...

Artificial Intelligence: Making Innovations Fit for the MDR

Thanks to artificial intelligence (AI), augmented reality (AR) has long shaped product development across a variety of areas, including the medtech industry.

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 on...

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 headquartered...

Lifestyle

It's March Madness! What organization was founded by a small group of physical educators and physicians who recognized that health problems were associated with certain lifestyle choices, especially smoking and lack of exercise?

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.

Education

In November 1848, what was the first medical school to open for women?

Health & Wellbeing

In July 1965, what landmark amendment was passed that helped drive medical innovation and improve the quality of healthcare?

Education

At the turn of the 19th century, what industry was so dangerous that surgeons became specially trained to address the unique injuries of its employees?

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.