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Advanced Level
Fundamentos del proceso de presentación de dispositivos médicos a la FDA de EE. UU.
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1.5-3 Avg Hours
CPD Accredited
Fundamentos del proceso de presentación de dispositivos médicos a la FDA de EE. UU.
Este curso en línea gratuito lo lleva por el camino de la comercialización de dispositivos médicos de conformidad con las regulaciones de la FDA de EE. UU.
La FDA de los Estados Unidos ha promulgado varios reglamentos y políticas para los fabricantes de dispositivos médicos que desean comercializar sus dispositivos médicos en los EE. UU. La inscripción en es... La FDA de los Estados Unidos ha promulgado varios reglamentos y políticas para los fabricantes de dispositivos médicos que desean comercializar sus dispositivos médicos en los EE. UU. La inscripción en este curso en línea lo familiarizará con los conceptos básicos de esta regulación y lo ayudará a comprender las diferentes vías de comercialización. También recibirá una breve orientación sobre la ISO 13485 y el 21 CFR, parte 820, las normas necesarias para establecer un sistema de gestión de la calidad en la industria de fabricación de dispositivos médicos.
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What You Will Learn In This Free Course
- Explain the global framework concer...
- Describe the major steps required t...
- Define the term "value proposition"...
- State the premarket requirements ne...
- Explain the global framework concerned with the regulations of medical devices
- Describe the major steps required to market a medical device
- Define the term "value proposition" in the context of medical device marketing
- State the premarket requirements needed to be fulfilled before placing a medical device into the US market
- Recognize the main similarities and differences between ISO 13485 and 21 CFR Part 820
- Outline the necessary resources for manufacturers regarding premarket submission
- Discuss the processions for a medical device manufacturer after submitting their medical device to the FDA
- Identify the essential regulatory and product testing components in the US medical device marketing context
- Indicate the different marketing pathways the FDA sets to help medical device manufacturers market their medical devices
- Distinguish the medical devices according to the risks they pose to the FDA
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Knowledge & Skills You Will Learn
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Learner Reviews & Feedback For Fundamentos del proceso de presentación de dispositivos médicos a la FDA de EE. UU.
Jurie Wessels V. ![]()
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Alison Graduate comprehensive course
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Alison Graduate If you need a comprehensive understanding of the medical device process, this is a good course.
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Learners Who Took This Course Also Enrolled In
- ISO 13485:2016 - Quality Management Systems for Medical Devices
- ISO 14971:2019 - Risk Management Application on Medical Devices
- 21 CFR Part 820 - Fundamentals of Quality System Regulation (QSR)
- Essentials of European Medical Device Regulations (EU MDR) - 2017/745
- ISO 15189:2022 - Medical Laboratories' Quality Assurance & Competence
- HIPAA Compliance: A Complete Guide
- Good Manufacturing Practices (GMP) for Safeguarding Product Quality
- Fundamentals of Federal Food, Drug, and Cosmetic Act (FD&C Act)