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...

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...

ZEISS Smartzoom 100 for Inspection Efficiency

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Discover ZEISS ZEN core – now for electron microscopy

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Clinigen Clinical Supplies Management GmbH

Integrated solutions for liquid handling

Greater efficiency for manufacturers in laboratory automation and many other industries

Swedish life science is growing – but capital is not keeping up

The number of employees and companies in Swedish life science is increasing and the sector is more equal than many other sectors. But investments in unlisted co...

Mercodia AB

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.

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...

Smartzoom 100 – The New Digital Microscope for Maximum Efficiency

Free webinar July 1, 9:00-9:45 AM CEST and 5:00-5:45 PM CEST.

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.

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...

New Insights into Microscopy

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Advanced workflow automation and scalable image analysis in spatial biology

ZEISS and Concept Life Sciences announce partnership.

The Future of Metrology is Coming to Your Region

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Meet us at Control 2025

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Explore the possibilities of the new ZEISS METROTOM 800 320 kV

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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...

Who pays for Rebecca Doe – and all of us?

Anna Törner on how easily we get used to the idea that healthcare is free - when it really is about how and who pays for it

Lund University’s record-breaking recruitment – attracting researchers from around the world

The Swedish university is launching its largest international recruitment effort ever, aiming to hire 25 researchers globally, including several in the medical field.

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...

Novo Nordisk tells staff to return to office

At the turn of the year, Novo Nordisk employees will no longer be able to work remotely. According to the company’s new CEO, the move is intended to accelerate ...

Novo Nordisk appoints Mike Doustdar as new CEO

The Danish pharmaceutical giant Novo Nordisk has appointed Mike Doustdar as its new CEO. At the same time, the company announced it was lowering its forecasts –...