Stockholm, Sweden
CoFounder and CEO at QAdvis
Medical Devices
Experience
QAdvis October 2013 - Present
Skills
GMP, FDA GMP, 21 CFR, QSR, Lean Software..., SharePoint, Quality System, Regulatory Requirements, Continuous Improvement, IEC 62304, CE marking, V&V, ISO 14971, Testing, FDA, Agile Methodologies, Six Sigma, Quality Management, R&D, Software, Quality Assurance, Quality Auditing, Biomedical Engineering, Digital Signatures, Design Control, Regulatory Affairs, Expert member of..., CAPA, TDD, Lean Sigma, Change Control, Validation, ISO 13485, 21 CFR Part 11, Regulatory Submissions, XP, Software Development, Medical Device Directive, Expert member of..., Scrum, Computer System..., RUP, Medical Devices, GxP, Lean Manufacturing, Process Improvement, DMAIC, Software Verification, Process Simulation, Test Driven Development