Executive Development Programme in Device Compliance Essentials
-- viendo ahoraThe Executive Development Programme in Device Compliance Essentials certificate course is a comprehensive program designed to provide learners with critical knowledge and skills in device compliance. This course is essential in today's rapidly evolving industry, where compliance is paramount to ensure the safety, effectiveness, and quality of medical devices.
5.550+
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
• Device Compliance Fundamentals: Understanding regulations, guidelines, and compliance requirements for medical devices. • Risk Management: Identifying, assessing, and mitigating risks in medical devices in accordance with ISO 14971. • Quality Management System: Implementing and maintaining a QMS based on ISO 13485, including document control, CAPA, and management review. • Design Control & Verification: Applying design control principles and verifying medical devices to meet user needs and intended use. • Clinical Evaluation & Validation: Conducting clinical evaluations and validations to demonstrate safety and performance. • Labeling & Instructions for Use: Designing and implementing compliant labeling and IFU to meet regulatory requirements. • Supply Chain Management: Managing suppliers and ensuring compliance throughout the supply chain. • Post-Market Surveillance & Vigilance: Monitoring and reporting adverse events and implementing corrective actions as needed. • Regulatory Affairs & Submissions: Navigating the regulatory landscape, preparing and submitting regulatory applications.
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
