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Orieta Paola Morales
Un dispositivo médico es cualquier instrumento, aparato, implemento, máquina, implante, reactivo para uso in vitro, software , material u otro artículo similar o relacionado a la prevención, el diagnóstico, el tratamiento y la rehabilitación de enfermedades y dolencias.
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Un dispositivo médico es cualquier instrumento, aparato, implemento, máquina, implante, reactivo para uso in vitro, software , material u otro artículo similar o relacionado a la prevención, el diagnóstico, el tratamiento y la rehabilitación de enfermedades y dolencias.
Read more
Un dispositivo médico es cualquier instrumento, aparato, implemento, máquina, implante, reactivo para uso in vitro, software , material u otro artículo similar o relacionado a la prevención, el diagnóstico, el tratamiento y la rehabilitación de enfermedades y dolencias.
En este curso, se presenta cómo lograr un proceso de trazabilidad por medio de los estándares de identificación GS1, con el fin de conocer el origen y autenticidad de cada dispositivo, para que el paciente sienta la confianza y seguridad de usarlo porque es legítimo y aporta a su salud.
Register for this course and see more details by visiting:
OpenCourser.com/course/smu4yf/identificacion
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What's inside
Learning objectives
- En los próximos módulos realizaremos un recorrido en el que aprenderemos sobre los estándares de identificación para los dispositivos médicos, con el objetivo de mejorar los procesos de trazabilidad y la seguridad del paciente. también, definiremos los atributos y requerimientos para capturar la información de los dispositivos médicos de acuerdo con la norma internacional.
- Finalmente, lograremos determinar el nivel de riesgo en el uso de los dispositivos médicos para capturar información adicional que impacta la seguridad del paciente e identificar la tipología para capturar la información de manera eficiente y adecuada según el tipo de dispositivo.
- En los próximos módulos realizaremos un recorrido en el que aprenderemos sobre los estándares de identificación para los dispositivos médicos, con el objetivo de mejorar los procesos de trazabilidad y la seguridad del paciente. también, definiremos los atributos y requerimientos para capturar la información de los dispositivos médicos de acuerdo con la norma internacional.
- Finalmente, lograremos determinar el nivel de riesgo en el uso de los dispositivos médicos para capturar información adicional que impacta la seguridad del paciente e identificar la tipología para capturar la información de manera eficiente y adecuada según el tipo de dispositivo.
Syllabus
Módulo Identificación:
Atributos básicos de los dispositivos médicos
Identificación de acuerdo con la jerarquía de producto
Clasificación de riesgo
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Syllabus
Módulo Identificación:
Atributos básicos de los dispositivos médicos
Identificación de acuerdo con la jerarquía de producto
Clasificación de riesgo
Read more
Atributos según clasificación de riesgo
Módulo Captura
Simbologías para capturar la información
Marcación directa de partes
Reglas para interpretación de las simbologías
Descripción de etiquetas
Impacto de no hacer una correcta marcación
Módulo Intercambio
Plataformas autorizadas para el intercambio de información
Base de datos Global de Identificación Única de Dispositivos – GUDID- en U.S.A por la FDA
Bibliografía
Encuesta de satisfacción
Good to know
Good to know
Know what's good ,
what to watch for , and
possible dealbreakers
Desarrolla conocimientos y habilidades importantes para la gestión de dispositivos médicos, lo que es esencial para la industria de atención médica
Se enfoca en los estándares de identificación GS1, que son ampliamente utilizados en la industria para rastrear dispositivos médicos
Proporciona una comprensión integral de la trazabilidad de dispositivos médicos, un tema crucial para garantizar la seguridad del paciente
Ofrece información sobre la clasificación de riesgos de dispositivos médicos, lo que ayuda a los alumnos a comprender las implicaciones de seguridad
Cubre varios aspectos de la gestión de dispositivos médicos, desde la identificación hasta el intercambio, lo que brinda una visión integral del proceso
Requiere conocimientos previos en el campo de la gestión de dispositivos médicos o un interés en el tema
Save this course
Save Identificación de dispositivos médicos (UDI) to your list so you can find it easily later:
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Activities
Be better prepared
before
your course. Deepen your understanding
during
and
after
it. Supplement your coursework and achieve mastery of the topics covered
in Identificación de dispositivos médicos (UDI) with these
activities:
General Overview of Medical Devices
Show steps
Refresher on the general overview of medical devices can help you connect with the terminology and concepts that we use throughout the course.
Browse courses on
Medical Device Regulation
Show steps
-
Review the course syllabus
-
Read the textbook chapters on medical devices
-
Watch online videos about medical devices
Explore Online Resources on Medical Device Traceability
Show steps
Explore online resources and tutorials to enhance understanding of medical device traceability concepts and GS1 standards.
Browse courses on
GS1 Standards
Show steps
-
Visit the GS1 website and review resources on medical device identification.
-
Search for and watch videos or tutorials on medical device traceability.
-
Read articles or blog posts on industry best practices and regulations.
Review Basic Medical Terminology
Show steps
Review medical terminology to become familiar with the vocabulary used in the course.
Browse courses on
Medical Terminology
Show steps
-
Study flashcards or online resources to learn medical terms.
-
Practice using medical terms in sentences or write short definitions.
Eight other activities
Expand to see all activities and additional details
Show all 11 activities
Design Flowchart for Traceability
Show steps
Creating a flowchart visualizing the traceability process can help you understand the flow of data and identify potential roadblocks.
Show steps
-
Map out the steps involved in the traceability process
-
Use a flowchart tool to create a visual representation
-
Share your flowchart with peers and instructors for feedback
Create a Glossary of Medical Terms
Show steps
Create a glossary of medical terms encountered in the course to reinforce understanding and improve retention.
Show steps
-
Define and provide examples for each medical term encountered in the course.
-
Organize the glossary alphabetically or by topic for easy reference.
-
Review and update the glossary regularly as new terms are introduced.
Discuss Best Practices for Medical Device Traceability
Show steps
Engage in discussions with peers to exchange ideas and learn from each other's experiences in implementing medical device traceability.
Show steps
-
Join or start a discussion forum or study group.
-
Share insights and experiences related to medical device traceability.
-
Seek feedback and learn from other participants.
Contribute to Open-Source Medical Device Software
Show steps
Contributing to open-source projects in the medical device domain can enhance your understanding of real-world applications and foster collaboration.
Show steps
-
Identify open-source medical device projects on platforms like GitHub
-
Select a project that aligns with your interests
-
Read the project documentation and make meaningful contributions
Compile a Resource Library on Medical Device Traceability
Show steps
Gather and organize a collection of resources to serve as a reference point for future learning and application of medical device traceability.
Browse courses on
GS1 Standards
Show steps
-
Identify and collect relevant articles, websites, videos, and other resources.
-
Organize and categorize the resources for easy access.
-
Use the library as a reference tool for ongoing learning and implementation.
Attend a Medical Device Traceability Workshop
Show steps
Attend a workshop to gain hands-on experience and deeper insights into medical device traceability practices.
Show steps
-
Research and identify relevant workshops or conferences.
-
Register for and attend the workshop.
-
Actively participate in sessions and engage with experts.
Develop a Patient Safety Plan
Show steps
Develop a patient safety plan to apply the knowledge gained in the course and enhance patient safety practices.
Browse courses on
Patient Safety
Show steps
-
Identify potential risks associated with the use of medical devices.
-
Develop strategies to mitigate risks and ensure patient safety.
-
Create a written plan outlining the steps to implement these strategies.
Mentor a Peer in Medical Device Traceability
Show steps
Share knowledge and provide guidance to a peer who is less familiar with medical device traceability, fostering deeper understanding and collaboration.
Show steps
-
Identify a peer who needs support in medical device traceability.
-
Offer guidance and support based on your knowledge and experience.
-
Provide resources and materials for further learning.
General Overview of Medical Devices
Show steps
Refresher on the general overview of medical devices can help you connect with the terminology and concepts that we use throughout the course.
Browse courses on
Medical Device Regulation
Show steps
Show steps
Show steps
- Review the course syllabus
- Read the textbook chapters on medical devices
- Watch online videos about medical devices
Explore Online Resources on Medical Device Traceability
Show steps
Explore online resources and tutorials to enhance understanding of medical device traceability concepts and GS1 standards.
Browse courses on
GS1 Standards
Show steps
Show steps
Show steps
- Visit the GS1 website and review resources on medical device identification.
- Search for and watch videos or tutorials on medical device traceability.
- Read articles or blog posts on industry best practices and regulations.
Review Basic Medical Terminology
Show steps
Review medical terminology to become familiar with the vocabulary used in the course.
Browse courses on
Medical Terminology
Show steps
Show steps
Show steps
- Study flashcards or online resources to learn medical terms.
- Practice using medical terms in sentences or write short definitions.
Eight other activities
Expand to see all activities and additional details
Show all 11 activities
Design Flowchart for Traceability
Show steps
Creating a flowchart visualizing the traceability process can help you understand the flow of data and identify potential roadblocks.
Show steps
Show steps
Show steps
- Map out the steps involved in the traceability process
- Use a flowchart tool to create a visual representation
- Share your flowchart with peers and instructors for feedback
Create a Glossary of Medical Terms
Show steps
Create a glossary of medical terms encountered in the course to reinforce understanding and improve retention.
Show steps
Show steps
Show steps
- Define and provide examples for each medical term encountered in the course.
- Organize the glossary alphabetically or by topic for easy reference.
- Review and update the glossary regularly as new terms are introduced.
Discuss Best Practices for Medical Device Traceability
Show steps
Engage in discussions with peers to exchange ideas and learn from each other's experiences in implementing medical device traceability.
Show steps
Show steps
Show steps
- Join or start a discussion forum or study group.
- Share insights and experiences related to medical device traceability.
- Seek feedback and learn from other participants.
Contribute to Open-Source Medical Device Software
Show steps
Contributing to open-source projects in the medical device domain can enhance your understanding of real-world applications and foster collaboration.
Show steps
Show steps
Show steps
- Identify open-source medical device projects on platforms like GitHub
- Select a project that aligns with your interests
- Read the project documentation and make meaningful contributions
Compile a Resource Library on Medical Device Traceability
Show steps
Gather and organize a collection of resources to serve as a reference point for future learning and application of medical device traceability.
Browse courses on
GS1 Standards
Show steps
Show steps
Show steps
- Identify and collect relevant articles, websites, videos, and other resources.
- Organize and categorize the resources for easy access.
- Use the library as a reference tool for ongoing learning and implementation.
Attend a Medical Device Traceability Workshop
Show steps
Attend a workshop to gain hands-on experience and deeper insights into medical device traceability practices.
Show steps
Show steps
Show steps
- Research and identify relevant workshops or conferences.
- Register for and attend the workshop.
- Actively participate in sessions and engage with experts.
Develop a Patient Safety Plan
Show steps
Develop a patient safety plan to apply the knowledge gained in the course and enhance patient safety practices.
Browse courses on
Patient Safety
Show steps
Show steps
Show steps
- Identify potential risks associated with the use of medical devices.
- Develop strategies to mitigate risks and ensure patient safety.
- Create a written plan outlining the steps to implement these strategies.
Mentor a Peer in Medical Device Traceability
Show steps
Share knowledge and provide guidance to a peer who is less familiar with medical device traceability, fostering deeper understanding and collaboration.
Show steps
Show steps
Show steps
- Identify a peer who needs support in medical device traceability.
- Offer guidance and support based on your knowledge and experience.
- Provide resources and materials for further learning.
Career center
Learners who complete Identificación de dispositivos médicos (UDI) will develop knowledge and skills
that may be useful to these careers:
Clinical Data Manager
Clinical Data Manager
Clinical Data Managers are responsible for the acquisition, management, and analysis of clinical data. Taking this course will provide you with the knowledge and skills necessary to understand the standards and regulations surrounding medical devices, which is essential for ensuring the accuracy and integrity of clinical data. The course will also help you to develop the skills necessary to identify and mitigate risks associated with medical devices, which is critical for protecting patient safety.
Regulatory Affairs Manager
Regulatory Affairs Manager
Regulatory Affairs Managers are responsible for ensuring that medical devices comply with all applicable laws and regulations. This course will provide you with the knowledge and skills necessary to understand the regulatory requirements for medical devices, and will help you to develop the skills necessary to prepare and submit regulatory documentation. The course will also provide you with an understanding of the principles of risk management, which is essential for ensuring the safety of medical devices.
Quality Assurance Manager
Quality Assurance Manager
Quality Assurance Managers are responsible for ensuring that medical devices are manufactured in accordance with all applicable standards and regulations. This course will provide you with the knowledge and skills necessary to understand the quality assurance requirements for medical devices, and will help you to develop the skills necessary to implement and maintain a quality assurance system. The course will also provide you with an understanding of the principles of risk management, which is essential for ensuring the safety of medical devices.
Medical Device Manufacturing Engineer
Medical Device Manufacturing Engineer
Medical Device Manufacturing Engineers are responsible for manufacturing medical devices. This course will provide you with the knowledge and skills necessary to understand the manufacturing process for medical devices, and will help you to develop the skills necessary to manufacture medical devices safely and effectively. The course will also provide you with an understanding of the principles of risk management, which is essential for ensuring the safety of medical devices.
Medical Device Marketing Manager
Medical Device Marketing Manager
Medical Device Marketing Managers are responsible for developing and executing marketing campaigns for medical devices. This course will provide you with the knowledge and skills necessary to understand the medical device industry, and will help you to develop the skills necessary to market medical devices effectively. The course will also provide you with an understanding of the principles of risk management, which is essential for ensuring the safety of medical devices.
Medical Device Regulatory Specialist
Medical Device Regulatory Specialist
Medical Device Regulatory Specialists are responsible for ensuring that medical devices comply with all applicable laws and regulations. This course will provide you with the knowledge and skills necessary to understand the regulatory requirements for medical devices, and will help you to develop the skills necessary to prepare and submit regulatory documentation. The course will also provide you with an understanding of the principles of risk management, which is essential for ensuring the safety of medical devices.
Medical Device Quality Engineer
Medical Device Quality Engineer
Medical Device Quality Engineers are responsible for ensuring that medical devices are manufactured in accordance with all applicable standards and regulations. This course will provide you with the knowledge and skills necessary to understand the quality assurance requirements for medical devices, and will help you to develop the skills necessary to implement and maintain a quality assurance system. The course will also provide you with an understanding of the principles of risk management, which is essential for ensuring the safety of medical devices.
Medical Device Safety Engineer
Medical Device Safety Engineer
Medical Device Safety Engineers are responsible for identifying and mitigating risks associated with medical devices. This course will provide you with the knowledge and skills necessary to understand the principles of risk management, and will help you to develop the skills necessary to identify and mitigate risks associated with medical devices. The course will also provide you with an understanding of the regulatory requirements for medical devices, which is essential for ensuring the safety of medical devices.
Medical Device Software Engineer
Medical Device Software Engineer
Medical Device Software Engineers are responsible for developing and maintaining software for medical devices. This course will provide you with the knowledge and skills necessary to understand the software development process for medical devices, and will help you to develop the skills necessary to develop and maintain software for medical devices safely and effectively. The course will also provide you with an understanding of the principles of risk management, which is essential for ensuring the safety of medical devices.
Medical Device Test Engineer
Medical Device Test Engineer
Medical Device Test Engineers are responsible for testing medical devices to ensure that they meet all applicable standards and regulations. This course will provide you with the knowledge and skills necessary to understand the testing process for medical devices, and will help you to develop the skills necessary to test medical devices safely and effectively. The course will also provide you with an understanding of the principles of risk management, which is essential for ensuring the safety of medical devices.
Medical Device Validation Engineer
Medical Device Validation Engineer
Medical Device Validation Engineers are responsible for validating medical devices to ensure that they meet all applicable standards and regulations. This course will provide you with the knowledge and skills necessary to understand the validation process for medical devices, and will help you to develop the skills necessary to validate medical devices safely and effectively. The course will also provide you with an understanding of the principles of risk management, which is essential for ensuring the safety of medical devices.
Medical Device Design Engineer
Medical Device Design Engineer
Medical Device Design Engineers are responsible for designing medical devices. This course will provide you with the knowledge and skills necessary to understand the design process for medical devices, and will help you to develop the skills necessary to design medical devices safely and effectively. The course will also provide you with an understanding of the principles of risk management, which is essential for ensuring the safety of medical devices.
Medical Device Packaging Engineer
Medical Device Packaging Engineer
Medical Device Packaging Engineers are responsible for designing and developing packaging for medical devices. This course will provide you with the knowledge and skills necessary to understand the packaging process for medical devices, and will help you to develop the skills necessary to design and develop packaging for medical devices safely and effectively. The course will also provide you with an understanding of the principles of risk management, which is essential for ensuring the safety of medical devices.
Medical Device Sales Representative
Medical Device Sales Representative
Medical Device Sales Representatives are responsible for selling medical devices to hospitals, clinics, and other healthcare providers. This course will provide you with the knowledge and skills necessary to understand the medical device industry, and will help you to develop the skills necessary to sell medical devices effectively. The course will also provide you with an understanding of the principles of risk management, which is essential for ensuring the safety of medical devices.
Medical Device Product Manager
Medical Device Product Manager
Medical Device Product Managers are responsible for managing the development and launch of new medical devices. This course will provide you with the knowledge and skills necessary to understand the medical device industry, and will help you to develop the skills necessary to manage the development and launch of new medical devices successfully. The course will also provide you with an understanding of the principles of risk management, which is essential for ensuring the safety of medical devices.
For more career information including salaries, visit:
OpenCourser.com/course/smu4yf/identificacion
Reading list
We've selected seven books
that we think will supplement your
learning. Use these to
develop background knowledge, enrich your coursework, and gain a
deeper understanding of the topics covered in
Identificación de dispositivos médicos (UDI).
Este documento proporciona orientación sobre las buenas prácticas de distribución para dispositivos médicos, que incluye información sobre la identificación y trazabilidad.
Esta guía proporciona una guía práctica para cumplir con los requisitos de GxP (Buenas Prácticas) para dispositivos médicos. Cubre los requisitos para la gestión de calidad, las prácticas de fabricación y el control de cambios.
Este documento proporciona una estructura estándar para la clasificación de productos sanitarios basada en su finalidad prevista y otras características.
Este libro ofrece una guía paso a paso para el diseño y desarrollo de dispositivos médicos. Cubre aspectos desde la identificación de necesidades hasta la producción y la comercialización.
Este libro proporciona una guía práctica para los fabricantes de dispositivos médicos sobre los requisitos reglamentarios aplicables.
Esta guía proporciona información sobre los requisitos de retiro de dispositivos médicos de la FDA.
Este libro de texto introduce los principios y aplicaciones del diseño experimental en la gestión de la calidad. Ofrece una base sólida para comprender cómo optimizar los procesos y mejorar la calidad en la industria de dispositivos médicos.
For more information about how these books relate to this course, visit:
OpenCourser.com/course/smu4yf/identificacion
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Effort
3 to 5 hours per week for 5 weeks
Level
Introductory
Via
edX
Institution
LOGYCA
Instructor
Orieta Paola Morales
Session
March 11, 2024
- May 3, 2024
Language
Español
Transcript
Español
Good to know
Desarrolla conocimientos y habilidades importantes para la gestión de dispositivos médicos, lo que es esencial para la industria de atención médica
Se enfoca en los estándares de identificación GS1, que son ampliamente utilizados en la industria para rastrear dispositivos médicos
Proporciona una comprensión integral de la trazabilidad de dispositivos médicos, un tema crucial para garantizar la seguridad del paciente
Ofrece información sobre la clasificación de riesgos de dispositivos médicos, lo que ayuda a los alumnos a comprender las implicaciones de seguridad
Cubre varios aspectos de la gestión de dispositivos médicos, desde la identificación hasta el intercambio, lo que brinda una visión integral del proceso
Requiere conocimientos previos en el campo de la gestión de dispositivos médicos o un interés en el tema
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