Will the FDA’s new transparency policy extend to medical devices? (Part 1)

, it may signal what’s ahead for medical devices.

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...

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 3)

As transparency and consistency become increasingly emphasized by the FDA, medical device manufacturers must approach their submissions with both thoroughness a...

New findings on the diseases that crushed Napoleon’s army

As if cold, starvation, and typhus weren’t enough. New research reveals that Napoleon’s defeated army also suffered from paratyphoid fever and relapsing fever d...

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...

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.

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...

Plug and play dräneringslösningar

En universalkoppling är en anordning som du placerar i din rörledning, och som ger dig friheten att enkelt och snabbt renovera och byta ut ångfällor. Detta mins...

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...

Gene therapy restored hearing in children with congenital deafness

Eleven out of twelve children with congenital deafness showed improvements in a study testing Regeneron’s gene therapy for hereditary hearing loss. The U.S. com...

After the threat of tariffs – Novartis invests 230 billion in the USA

Pharmaceutical giant Novartis plans to invest 23 billion dollarsover the next five years to expand its production in the USA. The goal is for all medicines dest...

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, ...

Genmab to Acquire Dutch biotech for USD 8 Billion

Danish pharmaceutical company Genmab has agreed to acquire Dutch firm Merus, a developer of cancer therapies, for USD 8 billion, equivalent to nearly SEK 75 billion.

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

ZEISS at EMO Hannover 2025

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

Experience innovations of the future

ZEISS QUALITY INNOVATIONS WORLDWIDE event in Oberkochen, Germany, January 20-21, 2026.

A cluster contribution to European life science innovation and competitiveness?

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.

Join our measuringhero Jay on the innovation tour

Experience our latest innovation from the Control fair.

FDA launches investigation into gene therapy following child death

The U.S. Food and Drug Administration (FDA) has initiated a safety investigation into Takeda’s Adzynma after reports that a child has died during treatment. The...

Rise and Scantox cease conducting animal testing in Stockholm

Access to in vivo toxicology services is significantly decreasing in the Stockholm area as Rise shuts down animal testing and Scantox reorganizes. ”The costs ar...

Shaping the Future of Metrology – Live in Your Region

Insights into our event series.

ZEISS Smartzoom 100 for Inspection Efficiency

Catch up on our free webinar.