Mästaren på peer review säger sällan nej till en studie

Statistikern Jonas Ranstam framhåller möjligheten att befinna sig i forskningens frontlinje som ett viktigt skäl att ägna sig åt granskning av medicinska studier.

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

Column: "Are we already living in the new normal?"

2020 felt like the year that we were building the house around us whilst moving into it at the same time.

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.

Materielbristen förväntas bli värre under veckan

Bristen på skyddsutrustning spås bli allt allvarligare de kommande dagarna i Sverige. Materielbristen är ett problem i flera länder och nu varnar New Yorks borg...

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, ...

Lucka 15 - vem finns här?

Det lackar mot jul och det vill vi uppmärksamma tillsammans med er. Varje dag fram till jul får vi här veta vad profiler i life science-världen har på sin önskelista.

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...

Höjer bud på Actelion

Johnson & Johnson diskuterar förvärv av det schweiziska läkemedelsbolaget, och uppges nu ha höjt sitt bud.

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