Executive Development Programme in MDR Documentation
-- viendo ahoraThe Executive Development Programme in MDR Documentation is a crucial certificate course designed to meet the growing industry demand for experts in Medical Device Regulation (MDR). This comprehensive programme imparts essential skills required to excel in MDR documentation, a critical aspect of medical device development and marketing.
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Detalles del Curso
โข MDR Fundamentals: Overview of Medical Device Regulation, key terminology, and regulatory framework
โข Classification of Medical Devices: Understanding the risk-based classification system for medical devices
โข Quality Management System: Implementing and maintaining a compliant Quality Management System (QMS)
โข Technical Documentation: Preparing and managing technical documentation, including Design Dossiers and Technical Files
โข Clinical Evaluation: Conducting clinical evaluations and preparing Clinical Evaluation Reports (CERs)
โข Post-Market Surveillance: Implementing and managing post-market surveillance and vigilance processes
โข MDSAP & International Regulations: Understanding the Medical Device Single Audit Program (MDSAP) and global medical device regulations
โข UDI & Traceability: Implementing Unique Device Identification (UDI) and traceability systems
โข Notified Bodies & Conformity Assessment: Working with Notified Bodies and navigating the conformity assessment process
Trayectoria Profesional
Requisitos de Entrada
- Comprensiรณn bรกsica de la materia
- Competencia en idioma inglรฉs
- Acceso a computadora e internet
- Habilidades bรกsicas de computadora
- Dedicaciรณn para completar el curso
No se requieren calificaciones formales previas. El curso estรก diseรฑado para la accesibilidad.
Estado del Curso
Este curso proporciona conocimientos y habilidades prรกcticas para el desarrollo profesional. Es:
- No acreditado por un organismo reconocido
- No regulado por una instituciรณn autorizada
- Complementario a las calificaciones formales
Recibirรกs un certificado de finalizaciรณn al completar exitosamente el curso.
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Preguntas Frecuentes
Tarifa del curso
- 3-4 horas por semana
- Entrega temprana del certificado
- Inscripciรณn abierta - comienza cuando quieras
- 2-3 horas por semana
- Entrega regular del certificado
- Inscripciรณn abierta - comienza cuando quieras
- Acceso completo al curso
- Certificado digital
- Materiales del curso
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