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Published Articles



Our experts are featured in industry-leading publications and provide deep insights into the science behind our services.



May 25, 2023

The MDR Delay’s Impact on Regulatory and Testing

Published In: Orthopedic Design & Technology (ODT)

“The MDR requires manufacturers to submit significantly more documentation covering the total product lifecycle than previously under the MDD. A...

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April 11, 2023

FDA Pilot Program Supports Streamlined Regulatory Submission Processes for Medical Device Manufacturers

Published In: Medical Design Briefs (MDB)

This article discusses the most recent FDA pilot program which supports streamlined regulatory submission processes for medical device manufacturers enhancing...

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March 1, 2023

The Bumpy Road to MDR

Published In: Medical Device and Diagnostics Industry (MD+DI)

“The [European Union’s] MDR aims to provide a higher level of protection for patients, but the transition has been anything...

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February 2, 2023

Considerations for Method Validation

Published In: Pharmaceutical Technology

In this article published in Pharmaceutical Technology, Susan Schniepp and Shiri Hechter explain how an analytical method to be used...

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October 7, 2022

Changes Related to Cleaning Validations

Published In: Medical Product Outsourcing (MPO)

The Association for the Advancement of Medical Instrumentation (AAMI) recently released the first cleaning validation standard for medical device manufactures, ANSI/AAMI ST98:2022...

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