Newsletter | June 16, 2022

06.16.22 -- FDA Releases Guidance On Cybersecurity In Medical Devices

 
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Industry Insights
Performance Of Bioprosthetic Heart Valves: Material Considerations

The treatment of severe cardiovascular disease has seen advancements that would have been considered impossible even 100 years ago, when the first surgical procedures were attempted. These advancements are a result of many lifetimes dedicated to furthering the understanding and treatment of cardiovascular disease. Modern developments in heart valve protheses have followed closely with advancements in available biomaterials.

Container Closure Integrity: A Risk-Based Approach

Container closure integrity is essential to protecting drug product and satisfying regulatory agencies. A risk-based approach enables creation of a robust data file for timely approval of regulatory applications.

Aqueous Critical Cleaning — Applications In Medical Device Manufacturing

Aqueous cleaners range in formulation from acidic to basic and from high emulsifying to low foaming, and the availability of liquid concentrates to powder blends ensures that a cleaner can be found to clean whatever residues are encountered, using whatever cleaning method is being used. 

Bioresorbable Copolymer Advances In Wound Healing, Pediatric Devices

Isabel Wahl, head of Evonik’s RESOMER development lab, discusses a new bioresorbable copolymer combining mechanical strength with rapid degradation for wound healing and pediatric devices.

Using Manufacturing Operations Management To Ramp Up Production For Medical Device Manufacturers
Discover how medical device manufacturers are leveraging a modern established manufacturing operations management (MOM) system coupled with manufacturing simulation and advanced planning and scheduling (APS) systems in order to optimize operations and improve agility during a disruptive time.
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