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.

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...

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...

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 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...

Integrated solutions for liquid handling

Greater efficiency for manufacturers in laboratory automation and many other industries

Shaping the Future of Metrology – Live in Your Region

Insights into our event series.

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...

New Horizons in Biologics & Bioprocessing incl. Advanced Therapies: Stockholm (2025)

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.

Discover the new ZEISS Axioscan 7 clinical

Your digital slide scanner for diagnostics & clinical research.

The Future of Metrology is Coming to Your Region

Join our event series.

A cluster contribution to European life science innovation and competitiveness?

GU Ventures AB

One System, Three Contrasting Techniques

ZEISS Axioscan 7 clinical - your digital slide scanner for diagnostics and clinical research.

ZEISS at EMO Hannover 2025

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

Meet us at Control 2025

Innovations that drive efficiency.

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...

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...

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...

Discover Precision: Join ZEISS at the Control Fair in Stuttgart

May 6-9, 2025 in Stuttgart. Hall 9, Booth 9309.

Southern Swedish company Aqilion develops drug for eosinophilic esophagitis

When Aqilion began developing a drug for eosinophilic esophagitis, the molecule was classified as an orphan drug. But the prevalence of the disease now appears ...

ZEISS Quality Innovations at CONTROL

May 6-9, 2025 in Stuttgart.

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...