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• Johannes Mueller

Personal information

• Wants

  Zielorientierte Menschen, Kontakte zu Fachexperten in den Bereichen Regulatory Affairs und Qualitätsmanagement - goal-oriented people, Regulatory Affairs and Quality Management contacts

• Haves

  Internationale Zulassungen von Produkten der Medizintechnik in: EU [CE-Zeichen], USA [510(k) & PMA], Kanada, China. International Regulatory Affairs: FDA-Zulassung, Lückenanalyse des QM-Systems nach FDA-Anforderungen (FDA-Inspection), FDA-Inspektionsvorbereitung, FDA-Compliance 21CFR820 (QSR): CAPA, 21CFR Part11 (Elektronische Aufzeichnungen Elektronische Unterschriften), FDA-Software Dokumentation, Software Validierung, IEC 62304, Re-engineering, Sicherheitsprüfungen, IEC 60601-x, Risikomanagement ISO 14971, Qualitätsmanagement, Audits u. Abweichungskorrekturen, ISO 13485, CMDCAS, CSA-Zeichen, Prozessgestaltung, Prozessvalidierung, Technische Dokumentation, Zertifizierung, US Agent, Klinische Studien in USA, CRO, internationales Projektmanagement auf Vorstand- u. Geschäftsführerebene. ________________(ENGLISH-Version:)_____________International Regulatory Affairs / Market Access for Medical Devices in: EU [CE-Mark], USA [510(k) & PMA], Canada, China. International Regulatory Affairs: FDA-Approval, Gap-Analysis of the Quality Management System according to FDA’s requirements (FDA-Inspection), Preparation of FDA-Inspections, FDA-Compliance 21CFR820 (QSR): CAPA, 21CFR Part11 (Electronic Records Electronic Signatures), FDA-Software Documentation, Software Validation, IEC 62304, Re-engineering, Safety Testing, IEC 60601-x, Risk Analysis, Risk Management ISO 14971, Quality Management, Audits & Correction of Findings + Non-Conformities, ISO 13485, CMDCAS, CSA-Mark, Prozess-design, Process-Validation, technical documentation, Certification, US Agent, Clinical Study in USA, CRO, International Project Management on CEO- and Board-Level

• Interests

  Badminton, USA______________ (ENGLISH-Version) Badminton, USA

• Organizations

  USA Association for the Advancement of Medical Instrumentation (AAMI), Joint Commission on Accreditation of Healthcare Organizations (JCAHO) Community, USA National Institute of Health (NIH) Forum

• Groups

  

• Employment status

  Executive

Educational background

• Languages

  German (First language), English (Fluent), French (Basic knowledge)