Black box i operationssalen ska göra kirurgin säkrare

Som enda svenska sjukhus använder sig Mora lasarett av black box vid titthålskirurgi. Förebilden är flygplanens svarta lådor, och metoden används flitigt i USA....

Marie Gårdmark: ”The situation is not satisfactory”

”The legislative tool-box is limited, but carrots in the form of longer exclusivity has already proven successful, this has for example increased registration o...

When carelessness, forgetfulness and coincidence become the researcher’s best friend

who were ready to think outside the box.

Adonis Stevenson vaknade ur koma

Boxaren som blev världsmästare och sedan hamnade i koma har nu äntligen vaknat till liv igen, något som även glädjer tidigare konkurrenten och vännen Badou Jack.

Nipeg Invest AB

Novandi Chemistry AB

Novitas Patent AB

PartnerTech AB

Pelago Bioscience AB

Scandinavian Medical Service

Science to Market - S2M

Skogsmöllan AB

SP Process Development

Testmentor

TFS International AB

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, ...

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...