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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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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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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 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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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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In-Depth Insights into the Most Useful ZEISS Metrology Expert Tips
Free webinar June 24th, 2025, 9:00-9:45 AM and 5:00-5:45 PM.
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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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Integrated solutions for liquid handling
Greater efficiency for manufacturers in laboratory automation and many other industries
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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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Strategic Clarity: The New Currency in Life Science
In an industry shaped by rapid regulatory changes and global competition, leading life science companies are rethinking what it takes to succeed. Increasingly, expert support is no longer a luxury—it’s a strategic necessity....
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Sustainability at Festo
On the Way to the Net Zero Era - New Sustainability Report published
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u2-Lok – rostfria dubbelklämringskopplingar för trygg drift
I industriella miljöer där vätskor och gaser transporteras under högt tryck eller vakuum krävs pålitliga förbindelser. u2-Lok från Schwer Fittings, tillgänglig ...
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Cost-efficient development of laboratory devices
8 ways to optimise development costs and speed up processes
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ZEISS showcases comprehensive workflow for full spectrum of retina care at EURETINA
ZEISS Medical Technology combines its diagnostic, surgical and digital technologies to support healthcare professionals in advancing retinal care.
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OEM Automatic levererar helheten för vatten och avlopp
Med kompletta lösningar för vatten och avlopp bidrar OEM Automatic till att hålla både små och stora vattenverk i drift. Sortimentet omfattar allt från mätning ...
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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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Optimera flödeshanteringen med Brooks Expert Support Tool (BEST)
Brooks Instrument erbjuder ett kraftfullt verktyg för dig som arbetar med digitala massflödesmätare och massflödesregulatorer. Med den Windows-baserade mjukvaran Brooks Expert Support...
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ZEISS Connected Quality: One metrology hub
The new product family ZEISS CONNECTED QUALITY is the solution for quick and secure data exchange, quality management and efficient system monitoring.
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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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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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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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From powder to implant
Quality assurance for additively manufactured implants.
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Nyckeln till rent vatten: OEM Automatic erbjuder smarta lösningar för turbiditetsmätning
Att mäta turbiditet är ett effektivt sätt att kontrollera vattenkvalitet – och en viktig del av en välfungerande vattenreningsprocess. OEM Automatic erbjuder ti...
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Join the premier metrology and quality assurance event of the year
ZEISS QUALITY INNOVATION SUMMIT in Berlin, October 22-24, 2024.
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