Newsletter | April 20, 2023

04.20.23 -- Increase In FDA Inspections & Whistleblower Complaints

Featured Editorial
Industry Insights
CCI For Combination Products: Assembling The Package Integrity Profile For Autoinjectors

Due to their complexity, combination products, specifically autoinjection systems, present unique challenges in implementing a container closure integrity testing strategy. Learn about these challenges and how to overcome them.

Change Control: Considerations For Medical Device Components

Explore the various factors that must be considered when faced with modifications, and what processes must be implemented in advance as part of a robust quality management system.

Medical Micromolding: Complex Problem Solving

Problem solving is what drives the medical device industry. For OEMs to successfully produce medical solutions, they often need to overcome manufacturing challenges. Whether manufacturing a micro component in-house or working with another molding supplier, sometimes OEMs hit roadblocks.

Early Decisions To De-Risk The Transition To Combination Products

The injectable product development landscape is changing, but the pressure to accelerate timelines remains constant. What can you do to overcome all the uncertainty and risk?

Have You Ever Failed A Design Verification Test For Your Drug Delivery Device?

If a drug delivery device fails a design verification test, the consequences can be lost revenue for the pharma company and delays for patients. Explore how to eliminate design verification failure.

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.

Selecting MLCCs That Meet The High-Reliability Requirements Of Medical Implantable Devices

Designing medical implantable devices for high reliability is crucial, but not straightforward. These devices are typically made up of many parts, including a variety of components, such as MLCCs.

Specialty LCP Compounds For Electronics Integration

In this article, Young Kim, Ph.D., senior principal engineer/chemist, Don DeMello, principal engineer field development, and Philip Wilson, Ph.D., marketing director medical, all with Celanese, discuss the benefits of recent advances in liquid crystal polymers for connected medical devices.

Neonatal Electrocardiogram (ECG) Electrodes For OEMs

Cardinal Health offers a variety of neonatal electrocardiogram (ECG) electrodes in different shapes, sizes, and substrates for neonatal and pediatric patients with delicate skin. These electrodes are available in large (L36) and small (L36-IB) sizes, include standard 18” – 24” length, color-coded wires, and are manufactured with conductive adhesive hydrogel for firm adhesion and reduced irritation.

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