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Innehållstyper
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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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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, ...
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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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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...
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RaySearch Laboratories AB
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Microbiotech/se AB
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Montex AB
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Nagarro Software
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NovaHep AB
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Omnio Healer AB
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Ortoway AB
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Össur Nordic AB
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Parker Hannifin AB
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Pfizer Health AB, Site Strängnäs
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PRV Patent- och registreringsverket
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Qiagen AB
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QMP Quality Maintenance Partner AB
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QPharma AB
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Quintiles AB
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Recopharma AB
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Redsense Medical
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Sanofi
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SHL Group AB
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Synergon AB - Göteborg
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