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PMS, Vigilance and Risk Management
Post-Market Surveillance (PMS) is more than complaint handling – it’s a strategic tool for patient safety, regulatory compliance, and continuous improvement. Un...
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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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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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Shaping regulatory complexity into strategic clarity
As AI continues to reshape healthcare, clear guidance on health data use is more critical than ever. Building on the success of the AI Act e-tool and the Data A...
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Norway rejects national life science strategy – sees no need
The Norwegian Arbeiderpartiet rejects a proposal that Norway should develop its own life science strategy.
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“Access to capital increases when there’s an exit”
It remains a tough environment for biotech companies seeking financing – but there is good reason to hope for improvement ahead. That’s the view of Okee William...
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Virology professor on the threat from X: ”The next pandemic could be worse“
The question is not if, but when we will be affected by a new unknown virus that causes yet another pandemic. Are we sufficiently prepared? "Absolutely not!", r...
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FDA approves Gilead’s HIV injection: “Historic day”
Gilead Sciences’ preventive HIV drug, lenacapavir, was approved on Wednesday by the U.S. Food and Drug Administration (FDA), sparking new hope for finally break...
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Cancer researcher: “We can do better and reduce suffering”
Lund University researcher Catharina Hagerling is developing innovative methods to understand metastatic cancer, aiming to create more targeted treatments for p...
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The business coach: “We need to learn from our mistakes”
The past year has been challenging for many biotech companies, with several comapanies facing financial stress and bankruptcy. To understand how entrepreneurs c...
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Sneak Peek of ZEISS Metrology Expert Tips Season 2
The second season of the video series starts in January 2026, but you can discover more about the highlights of Season 2 now.
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The vaccine has saved 94 million lives – but measles is spreading again
A disease we once believed belonged to the past is now resurging in both Europe and the United States. In the shadow of growing skepticism and declining vaccina...
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”We need compatibility“
Penilla Gunther, founder of Fokus Patient and chair of the European Patient Safety Foundation, hopes that the forthcoming life science strategy will focus on ef...
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Health politician Lina Nordquist: ”I find it hard to be idle”
of Parliament for the Liberals and their spokesperson on healthcare policy, to have a conversation about reality, politics, and the need for writing.
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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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Your solution for right part positioning
ZEISS OmniFix CT - right part positioning solution to get meaningful measuring results for all part sizes.
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How the Nobel discovery is used in drug development
Regulatory T cells keep the immune system in check, a discovery now awarded the 2025 Nobel Prize in Physiology or Medicine. Qiang Pan Hammarström explains how t...
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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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CDC ändrar info om autism – öppnar för möjlig vaccinkoppling
Påståendet ”vacciner orsakar inte autism” är inte evidensbaserat. Så beskriver numera den amerikanska folkhälsomyndigheten CDC sambandet mellan vacciner och aut...
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Achieve Effortless, Standardized Automation with the new ZEISS Automation Interface
Simple interfaces for automated loading of CMMs.
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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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Swedish team tests Alzheimer antibody for brain imaging
Recent breakthroughs in Alzheimer’s treatment have increased the need for precise diagnostics in the field. Researchers in Uppsala are working to develop improv...
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OEM Automatic i nytt samarbete med Schwer Fittings
OEM Automatic utökar sitt sortiment inom tryck- och flödesteknik genom ett nytt samarbete med den europeiska tillverkaren Schwer Fittings – specialister på kopplingar och rör i rostfritt stål. Genom samarbetet får svenska kunder nu enklare tillgång till...
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