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ABOUT US
Who we are
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PRRC
QA&RA manager for hire
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IVDR transfer process
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Medical Devices – Prestudy
Requirements analysis
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Medical Devices – Clinical evidence
Clinical Evidence
Clinical evaluation / Clinical investigation
Performance evaluation (IVD)
Medical Devices – Development
Risk management
Software risk management
Software validation
Software Quality Assurance
Quality management systems
Unique device identification
Product verification and validation
Computer systems validation
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GSPR
Medical Devices – Manufacturing
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Medical Devices – Market access
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Framtidens arbetsplats
(in swedish)
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Person Responsible for Regulatory Compliance (PRRC)
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Quality System Regulation, 21CFR820
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