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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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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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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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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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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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Quality assurance for research and development of medical devices
Overcome the hurdles of research, development, and QA lab environments within the regulated medical technology industry.
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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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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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Quality solutions for medical device R&D applications
From R&D to the quality assurance of series production in medical device manufacturing.
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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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After the threat of tariffs – Novartis invests 230 billion in the USA
Pharmaceutical giant Novartis plans to invest 23 billion dollarsover the next five years to expand its production in the USA. The goal is for all medicines dest...
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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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ZEISS introduces the new Smartzoom 100
The future of digital microscopy for efficient optical inspections.
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Korbinian Löbmann leads scientific meeting on drug formulation: High activity in the field
Korbinian Löbmann has moderated New Updates in Drug Formulation & Bioavailability several times before. Now he is once again taking on the scientific meeting. L...
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Rovtidskriftsjägaren om sin ärkefiende: ”Ondskans imperium”
Han myntade begreppet rovtidskrifter och gjorde ett första försök att kartlägga deras utbredning. Nu berättar bibliotekarien Jeffrey Beall om konsekvenserna det...
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Accelerate your Research with AI-Powered Image Analysis
Comprehensive eBook from ZEISS.
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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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SupraCube - In life Science
Superconductors must be permanently kept below their transition temperature for levitation. Because of the integrated cooler, applications with superconductors ...
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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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