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Medical technology / Medical equipment / Pharmaceutical industry / Validity / Quality management / Medical device / Medical Devices Directive / CE mark / Validation / Medicine / Technology / Health


Medical Information Systems – guidance for qualification and classification of standalone software with a medical purpose
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Document Date: 2013-01-31 07:31:38


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File Size: 492,51 KB

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Company

Welfare Git Eliasson / Health / Elekta AB / Medical Information Systems / Ericsson / /

Country

Sweden / /

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Facility

Royal Institute of Technology / /

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IndustryTerm

designated systems / registrator@mpa.se Internet / operations network / Active implantable medical devices / to many devices / Software qualification flow chart / risk management / devices / large advanced systems / information systems / similar and future systems / medicinal products / standalone software / software systems / diagnostic medical devices / /

MedicalCondition

disease / injury / /

Organization

National Board of Health and Welfare Git Eliasson / Swedish Standards Institute / Northern University Hospital / etc / Institute of Technology / European Commission / European Union / /

Person

Hans Ericsson / Erik Erlandsson / Peter Löwendahl / Lars Asteborg / Ronnie Lundström / /

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Position

Project Leader / /

ProvinceOrState

Maryland / /

Technology

cellular telephone / av / operating systems / /

URL

www.lakemedelsverket.se / /

SocialTag