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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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Organize and Manage Digital Classrooms
Create engaging lessons with ZEISS Labscope Teacher.
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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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Investment CEO: “The Nordics are outstanding in creating successful medtech companies”
Since the beginning of last month, Susanna Francke Rodau has been a partner and the new CEO of Segulah Medical Acceleration, which invests in medical technology...
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Improve Productivity and Accessibility with Award-winning Human-Centered Design
Enhance your workflow with integrated intelligence.
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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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She is CSL Behring's new Nordic General Manager
Since the beginning of january, Helena Bragd is the new Nordic General Manager for the biotech company CSL Behring and CEO of CSL Behring AB.
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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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Han är Gileads nya Nordenchef
Gilead Sciences har utsett Pau Arbos till ny till General Manager för Norden.
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Swedish life science is growing – but capital is not keeping up
The number of employees and companies in Swedish life science is increasing and the sector is more equal than many other sectors. But investments in unlisted co...
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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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Introducing ZEISS arivis Pro 4.2
Your solution for advanced image analysis and visualization.
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Anna Törner: ”Varför inte slå till på en ADHD-diagnos till kampanjpris?”
”Det är självklart positivt att neuropsykiatriska diagnoser inte upplevs som stigmatiserande, men just när det gäller ADHD kan jag inte låta bli att undra om de...
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Introducing ZEISS arivis Pro 4.2
ZEISS arivis software enhances custom microscopy image analysis.
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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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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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Roche joins Medicon Village
Roche and Medicon Village Innovation have signed an agreement for deeper collaboration. “The fact that Roche is now becoming part of this environment further st...
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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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US Health Secretary Kennedy dismisses all vaccine experts – assembles new committee
Robert F. Kennedy Jr. has dismissed all 17 members of the CDC’s vaccine advisory panel. A new group of experts will be appointed directly by the Health Secretar...
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