Newsletter | October 29, 2024

10.29.24 -- Computer Systems Validation Pitfalls, Part 1: Methodology Violations

FEATURED EDITORIAL

Computer Systems Validation Pitfalls, Part 1: Methodology Violations

When computer systems validation work is not performed according to protocol instructions — by cutting corners on quality outputs with the focus on profit as the main driver — this can result in drug and device companies losing profits and efficiencies.

INDUSTRY INSIGHTS

Beyond Making The Part: Understanding Enhanced Qualification

Working with a micro molder to develop an Enhanced Qualification (EQ) process for critical parts can save money and time by ensuring a smooth transition into full-volume production.

Embolization In The Treatment of Aneurysms

Coil embolization is a treatment for both aortic and cerebral aneurysms that fills the aneurysm with a coil-like material to close off the aneurysm sac and reduce the risk of bleeding or rupture.

The Hidden Costs Of Multiple-Vendor Contract Manufacturing

When it comes to outsourcing in medical device manufacturing, this article discusses these consequences and presents the advantages of working with a single-source contract manufacturer.

CM Partnering For Adaptable, Accelerated Market Acceptance

The need for manufacturing support that offers adaptable, scalable solutions has become more crucial than ever for the diagnostic space.

ARTICLES YOU MAY HAVE MISSED

The ABCs Of PCCPs (Predetermined Change Control Plans)

Sterility Assurance: The Fundamentals

Developing An Effective Patenting Policy To Protect AI-Enabled Medical Devices

A Look Inside The Growing U.S. Market Landscape For Surgical Navigation & Robotics

Improving Medical Device Testing With Robotic Automation

BULLETIN BOARD

Video: Nitinol Components

Nordson MEDICAL specializes in complex nitinol wire braiding and forming and provides innovative solutions for the medical device
industry from prototypes all the way through manufacturing.

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