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FDA’s new CSA guidance: transforming software validation for production and quality systems
FDA’s final guidance on Computer Software Assurance (CSA) for Production and Quality System Software marks a significant modernization of software validation practices.
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IVDR Reality Check: Are We Moving Fast Enough?
As of February 2025, around 1,500 IVDR certificates have been issued. But if an estimated 18,700 devices still need certification before the 2029 deadline, then...
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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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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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Quality assurance for research and development of medical devices
Overcome the hurdles of research, development, and QA lab environments within the regulated medical technology industry.
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Quality solutions for medical device R&D applications
From R&D to the quality assurance of series production in medical device manufacturing.
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ZEISS Lightfield 4D for instant volumetric high-speed imaging
Capturing physiological and neuronal processes in 3D.
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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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Cost-efficient development of laboratory devices
8 ways to optimise development costs and speed up processes
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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 dispensing of a viscous hydrogel
A suitable solution developed for UPM Biomedicals In the Festo LifeTech Application Center we tested a setup for UPM Biomedicals for the automatic dispensing of...
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Automated dispensing
Are you interested in automated dispensing of liquids?
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Efficient use of blood plasma
Blood plasma is an indispensable resource in the production of life-saving medicines. It is in high demand on global markets. To make more efficient use of this...
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Easy integration of piezo valves for gas handling
Extremely energy-saving, silent and without any heat build-up – piezo technology offers many benefits for efficient and precise gas handling in medical technolo...
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Extremely high sample throughput rates
Precision and reliability in automated liquid handling
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Saving lives worldwide with low-cost molecular diagnostics
High throughput testing for many upper respiratory tract pathogens thanks to automation technology
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Valves with piezo technology
Efficient control and regulation of gases in medical technology
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Flexibel ventilterminal från Festo
VTSA Terminalen från Festo är marknadens mest flexibla ventilterminal. Här kan du ansluta dina fria I/O signaler och styra hydrauliska rörelser. Du kan även bla...
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Flexibel ventilterminal från Festo
VTSA Terminalen från Festo är marknadens mest flexibla ventilterminal. Här kan du ansluta dina fria I/O signaler och styra hydrauliska rörelser. Du kan även bla...
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