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...

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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...

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...

A cluster contribution to European life science innovation and competitiveness?

Sarah Lidé: ”Artificial intelligence must not replace authentic interactions”

Artificial intelligence must never become a replacement for authentic, even if messy, interactions with our fellow humankind, Sarah Lifé, Deputy CEO at Medicon ...

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...

Investigations against AstraZeneca: ”Chinese interests may be behind them”

Why are there several investigations against AstraZeneca employees in China right now? Life Science Sweden continues to seek answers.

We desire talent to come here, but are we genuinely welcoming them?

Sweden faces significant challenges in creating a truly inclusive environment that makes international professionals feel welcome, valued, and able to build mea...

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...

Heart Monitoring in Breast Cancer – Essential or Excessive?

Trastuzumab and related drugs have transformed breast cancer treatment and dramatically improved survival rates. But the close cardiac monitoring required durin...

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...

BMS and venture capital giant form new company

The American pharmaceutical company Bristol Myers Squibb, together with the venture capital firm Bain Capital, is forming a new biotech company. The company wil...

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.

Aqilion's licensing journey: From Merck partnership to new opportunities

Be extremely meticulous with your scientific data, but spend just as much time and effort on business development. That piece of advice comes from Aqilion's CEO...

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.

Integrated solutions for liquid handling

Greater efficiency for manufacturers in laboratory automation and many other industries

An organ seldom in the spotlight – but utterly vital

The kidneys consist of more than 40 types of cells and have more functions in the body than most people know. Julie Williams leads AstraZeneca’s work in preclin...

The business coach: “We need to learn from our mistakes”

The past year has been challenging for many biotech companies, with several comapanies facing financial stress and bankruptcy. To understand how entrepreneurs c...

Ukraine war fuels rise of totally resistent bacteria

War-torn Ukraine is not just suffering from hostile attacks from a foreign aggressor, but also from the threat of a totally resistant and contagious bacteria.

Trump in new push to lower drug prices

U.S. President Donald Trump announced on Sunday that he plans to sign an executive order to lower the cost of prescription drugs to the same levels paid in othe...

Quality solutions for medical device R&D applications

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

Who pays for Rebecca Doe – and all of us?

Anna Törner on how easily we get used to the idea that healthcare is free - when it really is about how and who pays for it