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Robots Assemble Filters for Hospital Ventilators

July 8, 2021

At the beginning of 2020, Hervé de Malliard, CEO of systems integrator MGA Technologies in Civrieux d’Azergues, France, observed the first signs of the COVID-19 crisis.

Cavity Pressure Is the Key to Molding Consistent, Quality Parts

Pressure conditions in certain phases of the molding process correlate to specific attributes of the part.

Suzanne Graeser Bieri

June 9, 2021

Validation causes more headaches for medical device manufacturers than almost any other stage of the production process. For companies certified to ISO 13485, validation is always a costly and time-consuming undertaking, regardless of whether a new process is being set up or an existing process is being transferred.

Laser Marking Aids Compliance With UDI Regulations

John Sprovieri

February 10, 2021

In May, the European Union’s sweeping new Medical Device Regulation (MDR) will take effect. (The law had been scheduled to go into effect last May, but was postponed due to the COVID-19 pandemic.)

Gripper Automates Tube Handling

John Sprovieri

October 12, 2020

Based in Ilshofen, Germany, Bausch+Ströbel (B+S) manufactures filling and packaging equipment for the pharmaceutical industry.

Decontamination Device Prevents N95 Mask Waste

Zoe Leduc

June 15, 2020

As the coronavirus pandemic has continued to grow, personal protection equipment has become a necessity for more than medical professionals.

Surgical Tool Prototypes Developed With Additive Manufacturing

Zoe Leduc

February 6, 2020

Shukla Medical, a subsidiary of aerospace manufacturer S.S. White Technologies, designs and manufactures universal orthopedic implant removal tools such as the Xtract-All Spine Universal Spinal Implant Removal System. Their products are used by surgeons to preserve the patient's bone while removing old implants.

Preparing Metal Implants With Ultrasonic Cleaning

Zoe Leduc

October 2, 2019

Much of the conversation around medical device cleanliness is about sanitation and sterilization. While both are important for eliminating potentially harmful microorganisms, medical devices also need to be cleaned prior to sterilization.

Experience is key to leak testing

John Sprovieri

August 6, 2019

Flow and leak testing are required for any medical device that brings a substance to or from the body. Flow testing ensures that there are no blockages and the substance being delivered can make it through.

FDA to Modernize 510(k) Clearance Pathway

John Sprovieri

April 2, 2019

The Food and Drug Administration is changing the most common way it approves new low- to moderate-risk medical devices for use in the United States.

MDSAP Aims to Unifiy Standards for Auditing Medical Device Manufacturing Lines

Zoe Leduc

February 5, 2019

For medical device manufacturing, quality is crucial. To ensure quality in production, audits of the manufacturing facilities by a government health organization are standard. The audits and inspections are not, however, standard between countries. The Medical Device Single Audit Program (MDSAP) is looking to change that.

As we near entering year three of navigating both a global pandemic and continued digital transformation, we come together to reflect on challenges, achievement, progress and opportunities. A lively roundtable discussion examining where we’ve been, where we’re going and how to survive and thrive in the year ahead.