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OBS - rev 2 MDSAP Training for Medical Devices Manufacturers - en ESPAÑOL
Welcome
Bienvenidos (1:57)
Funcionamiento de la plataforma (6:28)
Quiz
Module 1 - Introductions, Structure and Basics
Material & Trainer's Curriculum
Presentación - MDSAP General (23:55)
Documentos - MDSAP General
Actividad - MDSAP General (14:09)
Quiz - MDSAP General
Cambios - Septiembre 2020
Cambios Sept 2020
Module 2 - Management Process
Presentación - Management (29:07)
Actividad - Management (4:24)
Documentos - Management
Quizz - Management
Module 3 - Market Authorization
Presentación - Market Authorization Tasks (16:46)
Documents - Market Authorization Tasks
Quiz - Market Authorization Tasks
Module 4 & 5 - Improvement and Adverse Event reporting.
Presentación - Measurement, Analysis and Improvement (18:31)
Presentación - Medical Device Adverse Events and Advisory Notices Reporting (15:30)
Actividad 1 - MAI (3:40)
Actividad 2 - MAI (7:35)
Documentos - MAI
Quiz - MA&I and Adverse events
Module 6 - Design and Development
Presentación - D&D Process (36:22)
Documentos - D&D Process
Actividad - D&D Process (6:02)
Quiz - D&D Process
Module 7 - Production and Service Controls process
Presentación - Production and Service Part 1 (31:27)
Actividad - Production and Service Part 1
Presentación - Production and Service Part 2 (33:41)
Actividad - Production and Service Part 2 (16:31)
Quiz - Production and Service Parts 1 & 2
Module 8 - Purchasing Process
Presentación - Purchasing Process (22:42)
Documentos - Purchasing Process
Quiz - Purchasing Process
The End
Conclusions (1:06)
Presentación - Production and Service Part 2
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