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Home » Authors » Elayne Gordonov

Elayne Gordonov

Elayne Gordonov, software product manager, Instron. For more information, call (800) 877-6674, email Elayne_Gordonov@instron.com or visit www.instron.com.

Articles

ARTICLES

mechanical testing data

Achieving Compliance with 21 CFR Part 11: Managing Electronic Testing Data

When transitioning from paper to electronic record keeping and Part 11, companies often have several solutions to choose from.
Elayne Gordonov
April 1, 2019
One Comment

FDA 21 CFR Part 11 compliance is mandatory for medical device and pharmaceutical companies that supply products into the United States.


Read More
Tortuosity testing systems

Mechanical Testing of a Stent: From Component Selection to Deployment Techniques

With stents and other implantable medical devices, the cost of failure can be extremely high.
Elayne Gordonov
June 8, 2018
No Comments

When arteries in the heart become blocked due to coronary artery disease, one of the ways to treat it is through the use of a coronary stent. These are tubular support devices that can be surgically implanted into the coronary arteries to keep them open, allowing the arteries to supply blood to the heart properly.


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gage repeatability and reliability

Gage Repeatability and Reliability: Ensuring Accurate Test Results for Measurement Systems

When designing a GR&R study it is important to select a range of materials that is representative of what the system will be used for.
Elayne Gordonov Morgan Galaznik
November 1, 2016
No Comments

One of the questions our applications team is most commonly asked is “Why aren’t my systems producing the exact same results?”


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Testing_FT

Why Medical Device Innovation Needs Quality Programs

The process of translating ideas into commercial products faces many challenges.
Elayne Gordonov Anna Wynn
April 1, 2015
2 Comments

Start-up medical device companies face a big challenge when it comes to resource budgeting for innovation and quality.


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testing_FT

The Challenge of Developing Testing Standards for Non-Standard Technology

Anna Wynn Elayne Gordonov
October 2, 2014
One Comment

Medical devices have always been a challenging field in which to develop testing standards.


Read More
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