Our experts are featured in industry-leading publications and provide deep insights into the science behind our services.
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...
June 7, 2022
Published In: Medical Device and Diagnostic Industry (MD+DI)
With the update to ISO 10993-18, is an extractables study required for all medical devices regardless of contact type and...
April 6, 2022
Published In: Parenteral Drug Association (PDA)
This article presents the first four steps of an initial evaluation roadmap for modern microbial methods. It is the result...
