Daniela I. Email & Phone Number

Experience with quality assurance, test management, risk management (ISO 14971), and quality management systems (ISO 13485/ISO 9001) for development of medical devices and maintenance of the regulatory documents for obtaining CE-marking and/or FDA approval. Specialties: Risk Analysis for active, implantable drop foot neurostimulator according to ISO 14791 ISO 13485, Quality Assurance, Internal Audit, Quality SystemsTechnical Standards (IEC 60606-1, ISO 14708-1, EN 980, ISO 15223-1)Design Dossier for CE-Marking approval under 90/385/EEC medical directiveFDA submission for Investigation Device Exemption (IDE)I believe in continuous learning from both practice & exchange experience as well as from furher education to strengthen and broaden my professional basis. Courses: Risk Management for Medical Devices and ISO 14971, Active Implantable Medical Device DirectiveISO 13485, Design Control for medical devices, Sterilization – Ethylene Oxide, Good Manufacturing Process (GMP), Process validation, The revised IEC/EN 60601–series, Six Sigma FoundationsCertifications: ISTQB Advanced Test Manager and ISTQB Software Testing FoundationProject Management, Certified SCRUM MasterInternal Audit Course in ISO 13485Specialties Test Management: Software Test Management, Test Strategy, Test Plans, Test Analysis, Test DesignRequirements Management, Release Management, Agile Testing, Scrum Teams, TMMI, T-MapCertified Scrum Master

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  Colorado State University Pueblo

  Computer Information Systems