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...

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...

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...

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...

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.

Pharma Outsourcing – Find the Right Partner (2025)

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...

The Future of Metrology is Coming to Your Region

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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...

Sarah Lidé: ”Artificial intelligence must not replace authentic interactions”

Artificial intelligence must never become a replacement for authentic, even if messy, interactions with our fellow humankind, Sarah Lifé, Deputy CEO at Medicon ...

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...

ZEISS at EMO Hannover 2025

Experience some of the most exciting highlights from our ZEISS product portfolio.

A cluster contribution to European life science innovation and competitiveness?

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...

Discover ZEISS ZEN core – now for electron microscopy

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New Insights into Microscopy

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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.

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.

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...

Integrated solutions for liquid handling

Greater efficiency for manufacturers in laboratory automation and many other industries

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.

An organ seldom in the spotlight – but utterly vital

The kidneys consist of more than 40 types of cells and have more functions in the body than most people know. Julie Williams leads AstraZeneca’s work in preclin...

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