FEATURED EDITORIAL
What Is Computer Software Assurance, And What Are Its Benefits?
By Kamila A. Novak, KAN Consulting
Kamila Novak reviews final computer software assurance (CSA) guidance and what it means for those working on medical device clinical trials.
Risk Is the Spine: What The First 100 QMSR Inspections Reveal
By Marcelo Trevino
The FDA has now completed just over 100 inspections under its new Quality Management System Regulation, and the agency has begun sharing preliminary observations from those inspections.
INDUSTRY INSIGHTS
Look, Ma! How I Solved These Disposable Diagnostic Device Challenges
Accumold
Developing The Right Low-Pressure Balloons For Medical Device Applications
Secant Group & Polyzen, part of the Solesis family of companies
EO Sterilization: Prepare For Stricter Residue Limits, Regulatory Shifts
Eurofins
USP Draft Chapters On CCS: What You Need To Know
West Pharmaceutical Services, Inc.
High-Volume Manufacturing: Essential Points To Consider
Pharma & MedTech Partner Division, B. Braun Medical Inc.
Pattern Bioscience Single Cell Microbiology To Decode Bacterial Infection
IDEX Health & Science, LLC
Success In Times Of Crisis: A Journey From Concept To Market In 8 Months
Medbio
