Newsletter | December 22, 2020

12.22.20 -- Risk-Based Postmarket Surveillance In The Age Of EU MDR: Incident Investigation

 
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Selecting The Right Tooling For High-Quality, Cost-Effective Molded Parts

Using the right combination of tooling and design for injection-molded parts will help ensure high-quality and cost-effective manufacturing.

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 (CCI) testing strategy. This is further complicated by a pervasive, though diminishing, tendency for companies to consider CCI only at the final product-package lifecycle stage, an approach where combination products will highlight the pitfalls.

Camera-Based Solutions For High-Content Imaging

This article will help readers to identify their needs and their options when implementing a new camera into a high-content imaging system.

Keys To Driving Consistent Quality In Contract Manufacturing

Complex products and supply chains present plenty of opportunities for failure, especially when new products are being developed and launched. This article discusses key ingredients to robust and advanced quality planning that is essential to quality in contract manufacturing.

Cleaning Validation For Medical Device Manufacturing

Cleaning validation or verification is a necessary regulatory compliance step in medical device manufacturing and reprocessing. Support from the cleaner manufacturer can save time and money.

Bioresorbable Copolymer Combines Mechanical Strength With Rapid Degradation For Wound Healing And Pediatric Devices

This interview with Isabel Wahl, head of Evonik’s RESOMER® development laboratory, discusses the use of a new bioresorbable copolymer that combines mechanical strength with rapid degradation for wound healing and pediatric devices.

Enhancing The Patient Experience For Self-Injection Systems

Patient self-injection for chronic disease treatments is on the rise. Due to the complexity of injectable treatment regimens, the disease management process, and patients’ emotional responses to changes in their lives related to their disease, onboarding aids such as reusable demonstration devices are becoming an increasingly prevalent and vital part of the patient onboarding process.

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