Astra Zeneca pauses multi-million investment in the UK

Astra Zeneca has paused a planned investment worth $270 million. It is the latest pharmaceutical company to pull back on its commitments in the UK.

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

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

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...

Astra Zeneca fryser miljardinvestering i Storbritannien

Astra Zeneca har pausat en planerad investering på motsvarande 2,5 miljarder kronor. Det är det senaste läkemedelsbolaget som drar tillbaka sina satsningar i Storbritannien.

Cost-efficient development of laboratory devices

8 ways to optimise development costs and speed up processes

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 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...

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...

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.

ZEISS announces CE mark for CIRRUS PathFinder AI tool with automated OCT assessment

Fully integrated AI decision support tool flags B scans that may require further review, supporting more confident decision making and more efficient patient care.

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.

The First Multi-Technology System from ZEISS

Microscope and measuring machine in one.

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.

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.

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...

GBA Key2compliance rekryterar Camilla Oldgren till ny vd

Från och med den 1 juni är det Camilla Oldgren som leder konsultföretaget GBA Key2compliance.

Medical device quality assurance

Recordings from ZEISS Quality Innovation Days.

Quality solutions for medical device R&D applications

From R&D to the quality assurance of series production in medical device manufacturing.

PMD Device Solutions i konkurs – kort efter börsdebut

PMD Device Solutions gjorde entré på börsen efter ett omvänt förvärv i december 2023. Bara drygt ett år senare har det svenska bolaget nu gått i konkurs och avnoterats.

Non-destructive testing and assembly control

Assess complete assembly.

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.

ZEN core now available for all ZEISS scanning electron microscopes

Introducing intuitive, streamlined SEM control over imaging, analytics, and multi-modal workflows.

A cluster contribution to European life science innovation and competitiveness?