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...

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...

Mentor Communications AB

SP Technical Research Institute of Sweden

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...

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.

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, ...

Bayer lägger bud på Algeta

Tysk-norsk storaffär ger bränsle i biotech-branschen. I Sverige stiger aktiekursen i bolag som Active Biotech.

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...

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...

RaySearch Laboratories AB

Microbiotech/se AB

Montex AB

Nagarro Software

NovaHep AB

Omnio Healer AB

Ortoway AB

Össur Nordic AB

Parker Hannifin AB

Pfizer Health AB, Site Strängnäs

PRV Patent- och registreringsverket

Qiagen AB

QMP Quality Maintenance Partner AB

QPharma AB