Generic filters
Exact matches only
Generic filters
Exact matches only
Header Artwork
Header Artwork

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...

Read the Published Article

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...

Read the Published Article

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...

Read the Published Article

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...

Read the Published Article

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...

Read the Published Article
of 19
Footer Artwork