8 Cursos
Fundamentals for the Medical Devices Industry
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
Fundamentals for the Medical Devices Industry
ISO 13485 Medical Devices
Learn about the requirements associated to the ISO 13485 Standard.
Duration: 4 hours
Modality: Group
Participant limit: 15
Fundamentals for the Medical Devices Industry
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
Fundamentals for the Medical Devices Industry
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: 2 hours
Modality: Group
Participant limit: 15
Fundamentals for the Medical Devices Industry
Good Documentation Practices
Learn the key elements of Good Documentation Practices for the medical device industry and the application when managing documentation and records.
Duration: 2 hours
Modality: Group
Participant limit: 15
Fundamentals for the Medical Devices Industry
Introduction to Process Validation
Learn the key concepts and fundamentals associated process validation cycle such as VMP, IQ, OQ and PQ, and the correlation with the regulations and standards.
Duration: 4 hours
Modality: Group
Participant limit: 15
Fundamentals for the Medical Devices Industry
Introduction to Design Controls
Learn about the quality practices and procedures that are incorporated into the product design and development process to ensure that a device is appropriate for its intended use.
Duration: 4 hours
Modality: Group
Participant limit: 15
