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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.
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Phase III win for Hansa Biopharma: “We Are Thrilled”
Swedish biotech Hansa Biopharma’s transplant drug imlifidase has met the primary efficacy endpoint in a registration-enabling Phase III study in the United States.
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A new life science cluster formed – “We are very strong in talent”
Stockholm and Uppsala’s joint life science cluster aims to be among the best in Europe. Pontus Holm, Life Science Coordinator for Region Stockholm, says the dec...
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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...
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Nya life science-klustret – ”Vi är fantastiskt starka inom talang”
Målet för Stockholm och Uppsalas gemensamma life science-kluster är att tillhöra toppen i Europa. Enligt Pontus Holm, life science-koordinator för Region Stockh...
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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...
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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...
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Hjärtövervakning vid bröstcancer sätts under lupp
Trastuzumab och efterföljande läkemedel har revolutionerat bröstcancervården och ökat överlevnaden markant. Men övervakningen av patienter för hjärtbiverkningar...
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Explore the possibilities of the new ZEISS METROTOM 800 320 kV
Free ZEISS webinar July 10, 9:00-9:45 AM and 5:00-5:45 PM.
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Pneumatics Makes a Technological Leap with Piezo
The first high-precision proportional valve terminal VTEP opens up new application areas
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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 ...
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Falska studiedeltagare – ett växande hot mot forskningen
Digital rekrytering blir allt vanligare vid hälsorelaterad forskning, men samtidigt ökar problemet med falska deltagare. Det hotar både resultatens tillförlitli...
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ZEISS receives FDA clearance for INTRABEAM 700
With its new treatment platform for intraoperative radiotherapy, ZEISS is actively shaping the medical innovation of neuro tumor therapy.
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Forskaren in Hagastaden now inagurated
The real estate company Vectura's life science center in Hagastaden, Forskaren, is now inaugurated. The opening was attended by people from the industry, politi...
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FDA approves Gilead’s HIV injection: “Historic day”
Gilead Sciences’ preventive HIV drug, lenacapavir, was approved on Wednesday by the U.S. Food and Drug Administration (FDA), sparking new hope for finally break...
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ZEISS introduces the new Smartzoom 100
The future of digital microscopy for efficient optical inspections.
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Pneumatics Makes a Technological Leap with Piezo
The first high-precision proportional valve terminal VTEP opens up new application areas
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Sensorer som lossnar och buggar i appar – fler klagomål på medicinteknik
Läkemedelsverkets nya e-tjänst för anmälan av problem med medicintekniska produkter har lett till en markant ökning av rapporter från privatpersoner. Särskilt m...
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ZEISS Lightfield 4D for instant volumetric high-speed imaging
Capturing physiological and neuronal processes in 3D.
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Organize and Manage Digital Classrooms
Create engaging lessons with ZEISS Labscope Teacher.
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Accelerate your Research with AI-Powered Image Analysis
Comprehensive eBook from ZEISS.
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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...
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Pulsen på patientförbunden del 1: Schizofreni
Schizofreniforskningen gör framsteg, bland annat genom en ökad förståelse för könsspecifika skillnader i behandlingsbehov. Nu efterlyser Schizofreniförbundet ny...
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Anna Törner: Vem betalar för Rebecca Doe – och alla oss andra?
Det lätt att vänja sig vid tanken att vård och läkemedel är gratis, när det egentligen handlar om hur och vem som betalar. Det skriver Anna Törner i en krönika.
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