When developing combination products or evaluating primary packaging for drug products one must evaluate the performance of ...

The combination product market is consistently expanding. Transitioning from traditional vial systems to needle-based ...

Every new medical device feature must live within a quality management system that tracks design control, risk management, ...

The SmartCombo is a precision bench-top, three- or four-axis automated catheter hole locating and drilling machine Technical Innovations, Inc.mbo is a precision bench-top, three- or four-axis ...

In Part 1 of this series, I explored how countries across the globe are shaping regulatory frameworks to manage the rapid integration of artificial intelligence (AI) and machine learning (ML) in ...

Centurion Vaginal Applicators were manufactured specifically to facilitate accurate placement of medication even in larger patients. Centurion Vaginal Applicators were manufactured specifically to ...

Most medical device designers and developers have some familiarity with the Q-Submission Program of the FDA. Relatively few, though, know how to best use the program to effectively speed the product ...

OPTIM Incorporated manufactures a line of nine insertion tube subassemblies, as well as endfitting and coil pipe components, for use in repairs of the most popular colonoscopes, gastroscopes and ...

The traditional 510(k) suggested format including, cover letter sample format, "Truthful and Accurate Statement" form, "Indications for Use" form, and submission sample format Institute of Validation ...

On the surface, unique device identification (UDI) is a simple concept. Put the device identifier (DI) on the device label in machine‑readable form. Include the production identifiers (PI) that you ...