13 Courses
Introduction to Medical Devices Industry
Learn an overview of medical device industry facts, types of medical device products, regulations and product market process submission.
Duration: 4 hours
Modality: Group
Participant limit: 15
21 CFR Part 820 – FDA Quality System Regulation
Learn about of the Code of Federal Regulations Title 21, Part 820, Understanding FDA Quality System Regulation and process to develop, manufacture and control a medical device product.
Duration: 4 hours
Modality: Group
Participant limit: 15
ISO 13485:2016 Medical Devices
Learn about the requirements associated to the ISO 13485 Standard, which are essential to the medical devices industry.
Duration: 4 hours
Modality: Group
Participant limit: 15
Good Manufacturing Practices
Learn about the key elements of Good Manufacturing Practices for the medical device industry involved in the manufacturing of medical products.
Duration: 4 hours
Modality: Group
Participant limit: 15
Good Documentation Practices
Learn about the key elements of Good Documentation Practices for the medical device industry and their application in managing documentation and records.
Duration: 4 hours
Modality: Group
Participant limit: 15
Fundamentals for the Medical Devices Industry
General Principles for Summary and Synthesis
The course focuses on developing skills to identify and understand the main issues in different situations, organize information, and improve the ability to summarize information concisely and clearly to express ideas effectively.
Duration: 4 hours
Modality: Group
Participant limit: 15
Introduction to Process Validation
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
Modality: Group
Participant limit: 15
Introduction to Design Controls
The course focuses on providing the student with a basic understanding of design controls for medical devices according to international regulations and standards.
Duration: 4 hours
Modality: Group
Participant limit: 15
Medical Devices Basics for Transportation and Logistics
This course provides an overview of the medical device industry, addressing product types, common regulatory concepts, applicable regulations and good manufacturing practices, with emphasis on basic packaging concepts and the sterilization process to ensure compliance with applicable regulations.
Duration: 6 hours
Modality: Group
Participant limit: 15
Technical Information
Introduction to Statistics
Introduction to Statistics is a practical course that provides students with a hands-on understanding of basic statistical tools.
Duration: 4 hours
Modality: Group
Participant limit: 15
Technical Information
General Principles for Effective Writing
The objective of this course is to provide students with the knowledge and skills needed to excel in the critical area of effective writing for change controls within the medical devices industry.
Duration: 3 hours
Modality: Group
Participant limit: 15
Technical Information
Fundamentals for the Medical Devices Industry
Effective Writing for Change Notices
The objective of this course is to provide students with the knowledge and skills needed to excel in the critical area of effective writing for change controls within the medical devices industry.
Duration: 3 hours
Modality: Group
Participant limit: 15
Technical Information
Fundamentals for the Medical Devices Industry
Risk Management Fundamentals
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
Modality: Group
Participant limit: 15
Technical Information