Event Price: $485,000 COP
Event price: 130 USD
Online payment: At the time of your registration you will be able to pay online with credit card and PSE.
Payment in banks:
Present the invoice printed in laser, and approach the following banking entities:
- Banco de Bogotá and its banking correspondents: Almacenes Éxito, Carulla, Surtimax, Súper inter.
Go to the University Cashier and pay with a debit or credit card.
Start date: 28-09-2021
End date: 04-11-2021
Duration: 25,00 hours.
Event city: Virtual CES platform
Hours: Tuesday, September 28, 2021. Program in virtual mode through the CES Virtual platform.
Location: CES Virtual platform
Event Code: 70114042
To register, you must fill out the form to generate the invoice and make the payment online, banks or in person at the University.
Know the importance of the topics to be addressed during the development of the course
We share the characteristics or requirements that you must meet to be part of this Course
The modality of the event is Virtual
The Medical Device (DM) industry is perhaps one of the industries with the greatest potential for development, growth and sustainability. Even in times of recession, the DM market is resilient and opens many doors to innovation and the development of new technologies. Designers, manufacturers, distributors and regulators work with the same purpose of guaranteeing and maintaining safe products that protect people's lives. In this course we will know some generalities about medical devices, we will navigate the clauses of the different standards applicable to the design and development of these, we will give explanations and practical examples that will serve students to have a better understanding of the different concepts and be in a good position to be able to prepare, implement and maintain a quality management system, in addition to understanding the process of design and development of medical devices, including risk management. This training will help to explore and understand the different requirements stipulated in the ISO standards, as well as to identify the best way to apply their principles and requirements to design and develop DM safely. This course is taught virtually, and is usually a precursor module of the Internal Auditor and Regulatory Affairs courses for INVIMA/EU/USA. It consists of presentations and workshop exercises.
Professionals and students in biomedical engineering and pharmaceutical chemistry, managers, directors and/or quality leaders of medical device manufacturers and/or marketers, directors of Regulatory Affairs, internal and external auditors who require competencies to audit Medical Device Systems, Health Professionals/Consultants, innovators and entrepreneurs new to the medical device industry or who want to update their knowledge about the aforementioned ISO standards, manufacturers, distributors or any individual seeking to acquire knowledge to work with DM based on ISO 13485 and ISO 14791 standards.
Find out how you can finance your registration in this event.
Find the contents to be dealt with in the Continuing Education Course
Learn about the skills that you will acquire by taking the Seminar at our University.
Finance the payment of your registration with SUFI, contact the advisor:
Anderson Esneyder Acevedo Benitez
Phone: (57) 604 604 91 25
Mobile: 301 254 98 44
Payment with Severance:
Check with your fund and severance management company about the requirements to make the payment *.
* Applies for diplomas and certifications.
- Module 1 General of medical devices. 3 hours
- Module 2 ISO 13485:2016 Standard – Requirements. 14 hours
- Module 3 Preparation, implementation and verification of the ISO standard. 4 hours
- Module 4 Risk management in medical devices. 4 hours
Evaluate international quality standards widely used in the design and development of DM, through the analysis of its different clauses and the review of industry examples in order to recognize the importance and added value that its use brings. This course will allow students to have sufficient foundations to face the development of a product and apply the standards.
Eng. Bme; MBA; Lead auditor; Senior Consultant Quality Management and Regulatory Affairs (QM/RA) at AstraZeneca, Munich, Germany. With 10 years of experience in the development and implementation of quality management systems, and their respective audits (EU, FDA, cFDA). I work hand in hand with DM design and development (RyD) teams, supporting compliance with the different quality standards required to demonstrate the safety and efficacy of the products to be marketed. Enthusiastic about boosting the Latin American DM industry and supporting the development of local markets.
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