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Home » Keywords: » FDA regulations

Items Tagged with 'FDA regulations'

ARTICLES

2025 Quality Rookie of the Year, Attrayee Chakraborty with the Rookie of the Year logo and a blurred background.
A Relentless Pursuit of Excellence

Meet the 2025 Rookie of the Year: Attrayee Chakraborty

Attrayee Chakraborty is a quality professional in the medical field, with a biotechnology background and expertise in AI.
Michelle Bangert
Michelle Bangert
April 29, 2025

Quality is honored to name Attrayee Chakraborty as our 2025 Quality Rookie of the Year. Discover how she earned the award through her groundbreaking work in medical device quality and AI integration.


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Q-cast article: Gregory J. Weaver

Podcast: Additive Manufacturing Inspection

June 26, 2024

Michelle Bangert, who is the managing editor of Quality, has a chat with Greg Weaver from Weaver NDT about additive manufacturing inspection.


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QM 0623 CLMN Speaking of Quality Mark Durivage
Speaking of Quality | Mark Durivage

Competence, Awareness, and Training – Oh My!

Consider preparing the workforce today for the challenges of tomorrow.
Mark Durivage
June 5, 2023

With the ever-increasing complexity involved with the provision of products and services, the demand for competent workers will undoubtedly increase.


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QM 0423 Software Pharma-laboratory pc screen closeup VectorPro tests
Software & Analysis

Quality Software: Core Qualities to Build Specialist Software Tools in QC Metrology

Manual operations cannot fully meet the challenges of a competitive and increasingly digitized industry.
Carl Bramley
March 28, 2023

We review essential software specifications and cover how those attributes can be leveraged when considering computer-controlled physical product testing equipment in the lab or on the shop floor.


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QM0320-FT-TestB-p1FT-optimization.jpg

Manufacturing Medical

Medical devices warrant high levels of traceability in order to obtain, track and analyze data.
Genevieve Diesing headshot
Genevieve Diesing
March 2, 2020

Medical devices can present unique challenges for manufacturers. Consequences for malfunctioning equipment can be dire. Because of this, medical device manufacturers must work hard to ensure that their products never fail.


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Acetabular Shell

Metrology for the Medical Field

Medical devices require stringent quality and inspection methods.
March 1, 2020

The medical industry stands out from other aspects of manufacturing. The inspection rates are often higher, quality is paramount, and the products could be implanted into the human body.


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compliance with regulations

Balancing Compliance and Continuous Improvement in Highly Regulated Industries

Learn how several innovative manufacturers are balancing compliance and continuous improvement in their operations.
Rony Kubat
October 8, 2019

Which is more important to you: complying with industry and federal regulations, or improving the efficiency and profitability of your operations?


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CAPA Processes

Why Product-Centric Quality Improves CAPA Processes

Ann McGuire
June 8, 2019

For medical device manufacturers, having a product that functions as designed is critical, as a person’s health—or even their life—could be at risk. It’s one thing if my Alexa won’t respond to a voice command to remind me of a task, but it may be life threatening if my asthma inhaler won’t give me the medication I need when I’m struggling to breathe.


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Medical Device Manufacturing

Medical Device Manufacturing

Michelle Bangert
Michelle Bangert
January 3, 2014
Whether it’s an insulin pump, respirator or pacemaker, medical devices obviously require extremely high quality.


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