Mikael Karlsson
Regulatory Affairs Specialist @A3P Biomedical
Stockholm, SE
EMAILS
MOBILE NUMBERS
+91 *********19
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WORK HISTORY
Jan 2023 — Present
Regulatory Affairs Specialist @A3P Biomedical
Stockholm, SE
EDUCATION
1995 — 2001
Uppsala University
MSc
1994 — 1995
Karlstad University
Pedagogy/Mathematics
SKILLS
Quality ManagementTechnical FilesThin FilmsDesign ControlProcess DevelopmentPhotolithographyQuality System ComplianceMemsProduct DevelopmentQuality SystemProcess SimulationIso 13485Quality AssuranceMaterials ScienceR&DDesign of Experiments
ABOUT MIKAEL KARLSSON
Specialties: IVD Regulation, IVD Medical Devices, IVD MDSW, SaMD,Quality Management Systems, ISO 13485, ISO 15189, ISO 14971, ISO 62366, ISO 62304, Design and Development Control, Production Control, Labelling, ISO/TR Process validation, Micro Systems Technology, MEMS, Process development, Master fabrication, CD-injection molding tools
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