Medizintechnik | Diagnostik
Alle Fachbereiche auf einen Blick: Medizintechnik & Diagnostik
Für Ingenieure und Naturwissenschaftler für den kompletten Produktlebenszyklus der Medical Device & Diagnostic Produkten von R&D über Quality, Produktion & Technik, Vigilance, Regulatory Affairs hin zu Sales & Marketing unserer Kunden.
RESEARCH & DEVELOPMENT
• Design Control (DHF)
• Project Engineering
• Project Management
• Risk Management
• Validation & Verification
• Testing
• Test Method Validation
• Biocompatibility
• Technical Documentation
• Document Review / Remediation
MEDICAL & CLINICAL AFFAIRS
• Clinical Project Management
• Clinical Research Associate (CRA)
• Clinical Safety
• Medical Advisor
• Medical & Scientific Writing
• Clinical Evaluation Reports
• Post Market Surveillance (PMS)
MANUFACTURING / PRODUCTION
• Clean Room
• Packaging / Labelling
• ProcessPlanning & Optimization
• Risk Management
• Site Planning
• Technology / Production Transfer
• Process Qualification
• Process Validation (DQ/IQ/OQ/PQ)
• Supply Chain Management (SCM)
REGULATORY AFFAIRS
• International Approvals
• UDI / Labelling
• Conformity
• Assessments / MDR
• NotifiedBodies
• Document Review / Remediation
QUALITY MANAGEMENT
• Auditing (Internal, Third Party)
• Risk Management
• NC, CAPA, Complaint
• CSV
• QMS
• QMB
• Quality Assurance (QA)
• Quality Control (QC)
• Supplier Management (SQA)
• Document Review / Remediation
• Life Cycle Management
CROSS-FUNCTIONAL ROLES
• Controlling & Accounting
• Human Resources
• Procurement
• Project Management
• Change Management
