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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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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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Teamator AB
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The MathWorks
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