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...

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...

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.

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...

TECHNIA AB

From powder to implant

Quality assurance for additively manufactured implants.

Kompauto Nordic AB

The Top 10 Challenges Facing Laboratories Today

Navigating the Laboratory Automation Landscape

Wusson Accelerator AB

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...

Automated nitrogen analysis reduces costs per sample

N-Realizer analytical system from C. Gerhardt increases productivity with valve block from Festo

New large lab building in Lund inaugurated – here are the companies moving in

Medicon Village has received a new laboratory building. On Friday last week the building was inaugurated with a ribbon-cutting ceremony by Minister for Employme...

Controlled Pneumatics: pushing the boundaries of pneumatics

Pressure, flow rate and movement can now be controlled very precisely, and with exactly the energy actually required. Controlled Pneumatics is the combination o...

Medhouse är med och lanserar GAPS - en global allians inom Life Science

Medhouse har tillsammans med 6 andra internationella konsultföretag skapat Global Alliance for Pharma Solutions (GAPS). Alliansen består därmed av ett robust in...

Life science trends 2025 – Neurology

New Alzheimer's drugs are beginning to be used in Sweden, more deals in the neuro sector are expected, and tools for deliver active substances across the blood-...

The future of healthcare in focus: ”Together, things happen”

In march, it’s once again time for Fokus Patient, an event for the industry where the patients’ perspective takes center stage. It’s a great way to spread knowl...

Danish obesity success causes recruitment problems in southern Sweden

The substantial expansion of Danish Novo Nordisk is affecting companies in southern Sweden, which are finding it increasingly difficult to compete for attractive staff.

Automated nitrogen analysis reduces costs per sample

N-Realizer analytical system from C. Gerhardt increases productivity with valve block from Festo

Security flaw in Swedish breast cancer screening software – woman passed away

A lack of safeguard in Sectra's software led to a woman with breast cancer receiving an incorrect diagnosis. She later passed away. The software is used in 20 o...

Extremely high sample throughput rates

Precision and reliability in automated liquid handling

Mikael Kubista back with new venture after turbulent exit

Entrepreneur and researcher Mikael Kubista is starting a new company. Now he is also free to comment on the sequence of events that led to him losing ownership ...

EU Pharmaceutical Legislation Reform

The EU's Pharmaceutical Legislation Reform, proposed by the commission within the European Health Union, aims to establish a citizen-centric framework to enhanc...