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Will the FDA’s new transparency policy extend to medical devices? (Part 1)
, it may signal what’s ahead for medical devices.
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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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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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Cost-efficient development of laboratory devices
8 ways to optimise development costs and speed up processes
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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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Exakt flödeskontroll för krävande industrier – med lösningar från Brooks Instrument
OEM Automatic erbjuder flödesmätare och regulatorer från Brooks Instrument – en globalt erkänd aktör inom mätning och reglering av gas- och vätskeflöden. Med öv...
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ZEISS announces CE mark for CIRRUS PathFinder AI tool with automated OCT assessment
Fully integrated AI decision support tool flags B scans that may require further review, supporting more confident decision making and more efficient patient care.
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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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How to Assure Quality within R&D Medical Devices
Free webinar on June 3rd, 2025, 9:00 - 9:45 AM CEST and 5:00 - 5:45 PM CEST.
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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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Explore the possibilities of the new ZEISS METROTOM 800 320 kV
Free ZEISS webinar July 10, 9:00-9:45 AM and 5:00-5:45 PM.
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The First Multi-Technology System from ZEISS
Microscope and measuring machine in one.
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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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Medical device quality assurance
Recordings from ZEISS Quality Innovation Days.
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ZEN core now available for all ZEISS scanning electron microscopes
Introducing intuitive, streamlined SEM control over imaging, analytics, and multi-modal workflows.
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Non-destructive testing and assembly control
Assess complete assembly.
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Smart styrning av pumpdrift i din bioprocessanläggning - Quattroflow Q-Control
Q-Control är en integrerad pumpstyrning (PID-regulator) för Quattroflow Multi-Use och Single-Use pumpar.
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Smart styrning av pumpdrift i din bioprocessanläggning - Quattroflow Q-Control
Q-Control är en integrerad pumpstyrning (PID-regulator) för Quattroflow Multi-Use och Single-Use pumpar.
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How to avoid measurement inaccuracies due to wear
Expert tip from ZEISS.
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Final assembly inspection of medical plastics
Technical paper by ZEISS Medical Industry Solutions.
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Precisionsmätning och flödesreglering med Brooks Instrument
OEM Automatic erbjuder ett brett sortiment av produkter från Brooks Instrument, en ledande aktör inom mätning och reglering av flöden. Brooks Instrument har sed...
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Quattroflow Q-Control - Smart styrning av pumpdrift i din bioprocessanläggning.
Quattroflow är en hermetisk pump utan axeltätningar som ger ett pulsationsfritt, kontrollerat och reglerbart flöde utan återläckage. Quattroflow är utvecklad fö...
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Enhance your expertise with your measuring software
Discover the training options in our ZEISS Metrology Portal.