Fundamentals for the Medical Devices Industry

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

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This course aims to provide students with the knowledge and skills necessary to excel in the critical area of effective writing for change controls within the medical device industry.

Duration: 3 hours

Modality: Group

Participant limit: 15

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The objective of this course is to provide students with the knowledge and skills needed to excel in the critical area of effective writing within the medical devices industry.

Duration: 3 hours

Modality: Group

Participant limit: 15

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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

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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

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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

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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

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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

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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

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Learn about the requirements associated to the ISO 13485 Standard.

Duration: 4 hours

Modality: Group

Participant limit: 15

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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: 6 hours

Modality: Group

Participant limit: 15

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