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.

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...

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.

Tre chefsrockader i CTR-koncernen

Forskningskoncernen Center for Translational Research (CTR) genomför flera skiften på ledande positioner. Flera av bolagen inom gruppen får nu nya chefer.

Roche joins Medicon Village

Roche and Medicon Village Innovation have signed an agreement for deeper collaboration. “The fact that Roche is now becoming part of this environment further 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...

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...

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...

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...

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.

Medivir i nytt avtal om cancerläkemedel i gelform

Svenska Medivir har ingått ett licenssamarbete med kanadensiska Biossil för fortsatt utveckling av Remetinostat, ett gelbaserat läkemedel som utvecklats för beh...

Lundabolag utvecklar nytt sätt att hitta dolda cancerceller

Lead Biologics rapporterar lovande prekliniska resultat för sin läkemedelskandidat som ska hjälpa immunförsvaret att upptäcka och bekämpa vissa cancerceller.

The Future of Swedish & Danish Life Science (2026)

Enhance your expertise with your measuring software

Discover the training options in our ZEISS Metrology Portal.

Conjugate Planes in Microscopy

Knowledge Article from ZEISS.

Fundamental Aspects of Airy Disk Patterns

Knowledge Article from ZEISS.

ZEISS introduces the new Smartzoom 100

The future of digital microscopy for efficient optical inspections.

Toxicology Knowledge Team Sweden AB

Karolinska ska bli ett europeiskt powerhouse för ATMP

Karolinska ATMP-centrum har ett enkelt men ambitiöst syfte: korta vägen mellan akademisk upptäckt och klinisk tillämpning. ”Vi önskar att Karolinska i framtiden...

Microscopy in Urinalysis: Observe Urine, Detect Abnormalities

Webinar on 18th March 2025, 10 AM - 11 AM CET.

Exakt flödeskontroll för krävande industrier – med lösningar från Brooks Instrument

OEM Automatic erbjuder flödesmätare och regulatorer från Brooks Instrument – en globalt erkänd aktör inom mätning och reglering av gas- och vätskeflöden. Med öv...

Mångmiljardbud på danska vaccinbolaget Bavarian Nordic

Ett konsortium lett av Nordic Capital och Permira planerar ett bud på danska vaccinbolaget Bavarian Nordic på 19 miljarder danska kronor, motsvarande 28,5 milja...

Alvotech utser Linda Jónsdóttir till ny finanschef

Linda Jónsdóttir har utsetts till ny Chief Financial Officer (CFO) på isländska Alvotech, noterade på Stockholmsbörsen.