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New version of ISO 10993-1: the core standard for the biological evaluation of medical devices
ISO 10993-1, the core standard for the biological evaluation of medical devices, has been under revision over the past few years. A Final Draft International St...
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Explore 3D Testing of Deformation and Motions
Powerful measurement capabilities with the new ZEISS ARAMIS 1.
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Could an overly burdensome QMS be the organization’s own doing?
Although the above statement is intentionally somewhat provocative, it does hold a degree of truth. Organizations that are generally negative toward regulations...
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Will the FDA’s new transparency policy extend to medical devices? (Part 1)
In a significant policy shift, the FDA has begun publishing Complete Response Letters (CRLs) for drug and biologic applications that were initially rejected but...
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The FDA’s new transparency policy (Part 3)
As transparency and consistency become increasingly emphasized by the FDA, medical device manufacturers must approach their submissions with both thoroughness a...
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The FDA’s new transparency policy (Part 2)
In the second part of our article series on the FDA’s new “radical transparency” initiative, we explore regulatory strategies to navigate the potential impact o...
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Spatial Biology Studies in Lung Tissue using Spectral Microscopy
Spectral imaging with the ZEISS LSM 980 laser scanning confocal enables more complex studies of cell-cell interactions and locations in immunology research.
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Automated nitrogen analysis reduces costs per sample
N-Realizer analytical system from C. Gerhardt increases productivity with valve block from Festo
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Pneumatics Makes a Technological Leap with Piezo
The first high-precision proportional valve terminal VTEP opens up new application areas
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Automated nitrogen analysis reduces costs per sample
N-Realizer analytical system from C. Gerhardt increases productivity with valve block from Festo
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SupraCube - In life Science
Superconductors must be permanently kept below their transition temperature for levitation. Because of the integrated cooler, applications with superconductors ...
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Compact and leak-tight powerhouse
Media-separated solenoid valve VYKA from Festo is virtually leak-free
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Pneumatics Makes a Technological Leap with Piezo
The first high-precision proportional valve terminal VTEP opens up new application areas
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Controlled Pneumatics: pushing the boundaries of pneumatics
Pressure, flow rate and movement can now be controlled very precisely, and with exactly the energy actually required. Controlled Pneumatics is the combination o...
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Superconductor technology: Contactless working in the laboratory of the future
Automated filling and weighing of freeze-dry containers in the cleanroom with SupraMotion from Festo
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Quality Assurance for the Highest Medical Standards
Metrology Solutions for Medical Components.
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Standardisation in automation
B. Braun Melsungen had a great idea and implemented it throughout the plant. Production for infusion solutions was to be largely standardised. B. Braun hoped th...
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The dock that “thinks” for itself
The world of bulk material handling seems straightforward at first glance: moving, filling, delivering. However, the art of dealing with a variety of different ...
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Precision and accuracy in liquid handling
How to evaluate and optimize liquid handling performance
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Nordic Regulatory experts: Improving biotech chances of Succ
Why is it that so many biotech companies fail? And what are the tools needed to change that fact?
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Valves with piezo technology
Efficient control and regulation of gases in medical technology
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