Masterclass Certificate in Regulatory Affairs for IVDs
-- viendo ahoraThe Masterclass Certificate in Regulatory Affairs for IVDs is a comprehensive course that provides learners with critical skills in the regulatory affairs sector, specifically for In Vitro Diagnostic (IVD) devices. This course is essential for professionals seeking to navigate the complex regulatory landscape and ensure compliance with IVD regulations.
3.412+
Students enrolled
GBP £ 149
GBP £ 215
Save 44% with our special offer
Acerca de este curso
HundredPercentOnline
LearnFromAnywhere
ShareableCertificate
AddToLinkedIn
TwoMonthsToComplete
AtTwoThreeHoursAWeek
StartAnytime
Sin período de espera
Detalles del Curso
• Introduction to Regulatory Affairs for IVDs: Understanding the regulatory landscape, key players, and regulations for In Vitro Diagnostic devices (IVDs)
• Classification of IVDs: Learning the risk-based classification system for IVDs and its impact on regulatory requirements
• Quality Management System (QMS): Implementing a QMS in compliance with ISO 13485 and FDA Quality System Regulation
• Clinical Evidence and Performance Evaluation: Generating and reporting clinical data to demonstrate the safety and performance of IVDs
• Labeling and Instructions for Use (IFU): Designing and reviewing labeling and instructions for proper use of IVDs
• Pre-market Notification (510(k)) and Approval (PMA): Navigating the FDA's pre-market review process for IVDs
• European Union (EU) Regulations for IVDs: Compliance with EU IVD Regulation (EU) 2017/746 and In Vitro Diagnostic Medical Device Regulation (IVDR)
• Post-market Surveillance and Vigilance: Implementing strategies for monitoring, reporting, and analyzing post-market data for IVDs
• Global Harmonization and International Regulations: Staying updated on global regulatory trends and international standards for IVDs
Trayectoria Profesional
Requisitos de Entrada
- Comprensión básica de la materia
- Competencia en idioma inglés
- Acceso a computadora e internet
- Habilidades básicas de computadora
- Dedicación para completar el curso
No se requieren calificaciones formales previas. El curso está diseñado para la accesibilidad.
Estado del Curso
Este curso proporciona conocimientos y habilidades prácticas para el desarrollo profesional. Es:
- No acreditado por un organismo reconocido
- No regulado por una institución autorizada
- Complementario a las calificaciones formales
Recibirás un certificado de finalización al completar exitosamente el curso.
Por qué la gente nos elige para su carrera
Cargando reseñas...
Preguntas Frecuentes
Tarifa del curso
- 3-4 horas por semana
- Entrega temprana del certificado
- Inscripción abierta - comienza cuando quieras
- 2-3 horas por semana
- Entrega regular del certificado
- Inscripción abierta - comienza cuando quieras
- Acceso completo al curso
- Certificado digital
- Materiales del curso
Obtener información del curso
Obtener un certificado de carrera
