Professionals in Management Systems for Quality and Regulatory Affairs located in Sweden but working World Wide.

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Quality  Management System ; Consulting ; Audits ; Training , Education

Risk Management

Outsourcing Quality Function

Medical Devices and In Vitro Diagnostic Devices CE marking

Sweden LVFS 2009:18 , LVFS 2001:7 , LVFS 2001:8

EU Directives , 93/42/EC , 98/79/EC

US Regulations , 21CFR820 , 21CFR809 , GMP , GLP

Standards ISO 9001 ; ISO 13485 ; ISO 14971 ; ISO 19011 , GHTF

Telecommunication , IT , Intranet , Document Control , Document Management

Webhosting quality management system