Medical Device Archives

How to Ensure Speed and Quality in Medical Device Manufacturing

Blog Post

How to Ensure Speed and Quality in Medical Device Manufacturing

In today’s competitive and fast-paced manufacturing industry, medical equipment manufacturers are actively seeking ways to produce high-quality medical devices in the quickest way possible.

March 17, 2022

3 Ways the Digital Enterprise Can Better Navigate Uncertainty in Today’s Marketplace

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3 Ways the Digital Enterprise Can Better Navigate Uncertainty in Today’s Marketplace

As the world fights the coronavirus, it is quickly becoming evident that “business as usual” no longer applies. New business models will be evaluated, and massive “pivots” may be needed to meet the evolving needs of our society. The Digital Enterprise is best poised to be part of the new “non-normal” environment we now operate in.

March 27, 2020

Why Medical Manufacturers Need Manufacturing Operations Management (MOM)

Blog Post

Why Medical Manufacturers Need Manufacturing Operations Management (MOM)

In the world of medical device manufacturing, mistakes on the plant floor can have dire consequences. That’s why meeting FDA requirements such as 21 CFR Part 820, 21 CFR Part 11 and ISO 13485 are so critical.

December 15, 2016

Why Earlens Selected Solumina as Their MES Solution

Blog Post

Why Earlens Selected Solumina as Their MES Solution

Earlens will be installing iBASEt’s Solumina at its corporate headquarters to manage production in this innovative environment.

November 03, 2016

Does Your MES Support Effective Product Genealogy for Medical Device Manufacturing?

Blog Post

Does Your MES Support Effective Product Genealogy for Medical Device Manufacturing?

In today’s global medical device manufacturing environment, supply and manufacture is more dispersed and nuanced than it ever has been.

October 06, 2016

Blog Post

The Impact of ISO 13485

The publication of the ISO 13485:2016 standard in March of this year realizes work that began in July 2014 with the rejection of the first Draft International Standard (DIS)

August 03, 2016

Achieve Cradle-to-Grave Bi-Directional Traceability with Best-of-Breed MOM

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Achieve Cradle-to-Grave Bi-Directional Traceability with Best-of-Breed MOM

Globally, medical device manufacturers continue to face stricter government regulations and escalating costs.

July 15, 2016

Waiting for an eDHR Mandate? Best-in-Class Medical Device Manufacturers are Already There

Blog Post

Waiting for an eDHR Mandate? Best-in-Class Medical Device Manufacturers are Already There

In today’s highly competitive, fast-paced medical and diagnostic device industry, manufacturer’s often struggle to find the right time to shift away from their costly, inefficient and error-prone processes, such as assembling a DHR (Device History Record) from multiple paper and spreadsheet sources.

March 24, 2016

Aerospace & Defense

What is Complex Discrete Manufacturing?

Complex discrete manufacturing industries manufacture complex highly engineered products with longer product cycle times and multiple levels of subassemblies in their bills of material.

March 04, 2016

A Better Approach to Maintaining Device History Records for FDA Compliance

Blog Post

A Better Approach to Maintaining Device History Records for FDA Compliance

Current FDA regulations encourage medical device companies to use the latest collection technologies and improve their delivery systems.

March 02, 2016

3 Reasons You Might Fail During a Software Implementation and How to Avoid Them

Aerospace & Defense

3 Reasons You Might Fail During a Software Implementation and How to Avoid Them

Recently, I was involved in a sales call with a major medical device manufacturer. While exchanging goodbyes, the EVP said, “This implementation has to work.” For prospective buyers those words seem to be all too common.

February 11, 2016

New Acronyms from the FDA: UDI and GUDID

Blog Post

New Acronyms from the FDA: UDI and GUDID

On September 24, 2013, the FDA established a Unique Device Identification (UDI) system to identify all medical devices sold in the U.S. starting from the point of manufacture, through all distribution channels, and to the eventual sale to the consumer.

January 28, 2016

Category: Medical Device