Our experts are featured in industry-leading publications and provide deep insights into the science behind our services.
March 1, 2023
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...
February 2, 2023
Published In: Pharmaceutical Technology
In this article published in Pharmaceutical Technology, Susan Schniepp and Shiri Hechter explain how an analytical method to be used...
October 7, 2022
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...
September 17, 2022
Published In: Orthopedic Design and Technology (ODT)
With the rise of orthopedic device evaluation and updating of standards, testing laboratories must be at the forefront of analytical...
June 24, 2022
Published In: American Pharmaceutical Review
In this article Steve Lynn from Regulatory Compliance Associates discuss why the top 10 FDA Form 483 issues have remained...
