The objective of this course is to level and harmonize risk management knowledge for the entire population using risk documents within the context of the medical device industry.
Duration: 9 hours
CEUs: 1.0
Modality: Group
Participant limit: 15
The objective of this course is to provide the student with a comprehensive overview of fundamental statistical principles and tools. Central tendency metrics, dispersion analysis, distribution fit, hypothesis testing and graphs creation and interpretation are tools that allow students to describe and compare data behaviors, identify desirable and undesirable conditions related with the process or data collection procedure. Appropriate data description and analysis are the first step in many mayors decision-making processes in the Medical Devices Industry, consequently, it becomes crucial knowledge for engineers in the industry. This course is given with the support of software traditionally used in this industry and based on application cases.
1. Introduction to statistics and basic concepts
2. Descriptive Statistics
3. Commonly used graph for data analysis
Introduction to Statistics is a practical course that provides students with a hands-on understanding of basic statistical tools.
Duration: 4 hours
CEUs: 0.5
Modality: Group
Participant limit: 15
Introduction to Statistics is a practical course that provides students with a hands-on understanding of basic statistical tools.
Duration: 4 hours
CEUs: 0.5
Modality: Group
Participant limit: 15
The objective of this course is to level and harmonize risk management knowledge for the entire population using risk documents within the context of the medical device industry.
Duration: 9 hours
CEUs: 1.0
Modality: Group
Participant limit: 15
Learn the key concepts and fundamentals associated with the process validation cycle, such as VMP, EQ, TMV, OQ and PQ, and the correlation with regulations and standards.
Duration: 4 hours
CEUs: 0.5 hours
Modality: Group
Participant limit: 15
Learn about the requirements associated to the ISO 13485 Standard.
Duration: 4 hours
CEUs: 0.5 hours
Modality: Group
Participant limit: 15
Learn an overview of medical device industry facts, types of medical device products, regulations and product market process submission.
Duration: 4 hours
CEUs: 0.5 hours
Modality: Group
Participant limit: 15
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