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   COURSES FOR COMPANIES
   
   
   FUNDAMENTALS FOR THE MEDICAL DEVICES INDUSTRY (11)
   
   
   PROCESS VALIDATION AND SUSTAINING (8)
   
   
   STATISTICS FOR MEDICAL DEVICES MANUFACTURING (4)
   
   
   QUALITY AND COMPLIANCE FOR MEDICAL DEVICES INDUSTRY (4)
   
   
   DESIGN CONTROLS FOR MEDICAL DEVICES (2)
   
   
   FUNDAMENTALS OF PROJECT MANAGEMENT FOR ENGINEERS (1)
   
   
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   COURSES FOR COMPANIES
   
   
   FUNDAMENTALS FOR THE MEDICAL DEVICES INDUSTRY (11)
   
   
   PROCESS VALIDATION AND SUSTAINING (8)
   
   
   STATISTICS FOR MEDICAL DEVICES MANUFACTURING (4)
   
   
   QUALITY AND COMPLIANCE FOR MEDICAL DEVICES INDUSTRY (4)
   
   
   DESIGN CONTROLS FOR MEDICAL DEVICES (2)
   
   
   FUNDAMENTALS OF PROJECT MANAGEMENT FOR ENGINEERS (1)
   
   
   BECOMING A SUPPLIER FOR THE MEDICAL DEVICES INDUSTRY (1)
   
   
   TECHNICIAN AND OPERATOR DEVELOPMENT (15)
   
   ONLINE COURSES
   
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   COURSES FOR COMPANIES
   
   
   FUNDAMENTALS FOR THE MEDICAL DEVICES INDUSTRY (11)
   
   
   PROCESS VALIDATION AND SUSTAINING (8)
   
   
   STATISTICS FOR MEDICAL DEVICES MANUFACTURING (4)
   
   
   QUALITY AND COMPLIANCE FOR MEDICAL DEVICES INDUSTRY (4)
   
   
   DESIGN CONTROLS FOR MEDICAL DEVICES (2)
   
   
   FUNDAMENTALS OF PROJECT MANAGEMENT FOR ENGINEERS (1)
   
   
   BECOMING A SUPPLIER FOR THE MEDICAL DEVICES INDUSTRY (1)
   
   
   TECHNICIAN AND OPERATOR DEVELOPMENT (15)
   
   ONLINE COURSES
   
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   FDA (21 CFR 820) REGLAMENTO SOBRE EL SISTEMA DE CALIDAD PARA DISPOSITIVOS
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 * Consulting
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 * Training Solutions
   
   COURSES FOR COMPANIES
   
   
   FUNDAMENTALS FOR THE MEDICAL DEVICES INDUSTRY (11)
   
   
   PROCESS VALIDATION AND SUSTAINING (8)
   
   
   STATISTICS FOR MEDICAL DEVICES MANUFACTURING (4)
   
   
   QUALITY AND COMPLIANCE FOR MEDICAL DEVICES INDUSTRY (4)
   
   
   DESIGN CONTROLS FOR MEDICAL DEVICES (2)
   
   
   FUNDAMENTALS OF PROJECT MANAGEMENT FOR ENGINEERS (1)
   
   
   BECOMING A SUPPLIER FOR THE MEDICAL DEVICES INDUSTRY (1)
   
   
   TECHNICIAN AND OPERATOR DEVELOPMENT (15)
   
   ONLINE COURSES
   
   Quick View
   
   
   
   BUENAS PRÁCTICAS DE DOCUMENTACIÓN PARA LA INDUSTRIA MÉDICA (ONLINE)
   
   Online
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   FDA (21 CFR 820) REGLAMENTO SOBRE EL SISTEMA DE CALIDAD PARA DISPOSITIVOS
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School of Medical Devices
Strengthening the talent for the medical device industry
School of Medical Devices
Training for medical devices industry
School of Medical Devices
Medical Device Manufacturing Business Solutions
Advancing your skills for tomorrow
Search for:
School of Medical Devices
Strengthening the talent for the medical device industry
School of Medical Devices
Training for medical devices industry
School of Medical Devices
Medical Device Manufacturing Business Solutions
Advancing your skills for tomorrow
Search for:
School of Medical Devices
Strengthening the talent for the medical device industry
School of Medical Devices
Training for medical devices industry
School of Medical Devices
Medical Device Manufacturing Business Solutions
Advancing your skills for tomorrow
Search for:
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Strengthening Your Career on Medical Devices Design and Manufacturing


We are a leading educational and consulting firm specialized on the Medical
Device Industry.

Our learning model IndustryON makes learning engaging and effective, so you
implement the best practices and techniques from the industry to achieve your
professional goals.




SERVICE SOLUTIONS



Our professional team works together with yours to create and provide training,
engineering, quality and compliance solutions to support the design and
manufacture of medical devices.


TRAINING



21 CFR PART 820 – FDA QUALITY SYSTEM REGULATION



APPLIED STATISTICS IN MEDICAL DEVICES MANUFACTURING



AUDIT PROCESS AND READINESS



AUDITS AND FAILURES TO THE QUALITY SYSTEM



BASICS OF LINE CLEARANCE



BASICS OF MECHANICAL DRAWING INTERPRETATION



BASICS OF NONCONFORMITIES



BASICS OF PROCESS CONTROLS AND INSPECTIONS




CONSULTING


 * ISO 13485
 * Audits
 * Quality System Regulations
 * Lean Six Sigma
 * Manufacturing Gap Assessment
 * Manufacturing Quality
 * Transfer Due Diligence
 * Practice vs Procedures Gap Assessment


WHAT SMD CAN DO FOR YOU



We work in collaboration with our customers to understand and identify their
needs, and thus, develop training and high-value solutions to exceed their
expectations.


TALENT DEVELOPMENT

From operators to engineers we have created a series of meaningful and
applicable training to the medical device industry that will help our students
to boost their path for success.


LEARNING CURVE ACCELERATION

Our learning model seeks to accelerate the students’ learning curve through the
resolution of industry real-life cases that will help them experience the
medical industry firsthand.


INDUSTRY GROWTH

We are an experienced team ready to support medical devices manufacturers to
improve their quality system, maintain regulatory compliance and implement
engineering solutions suitable to their needs.


THE RESULTS SPEAK FOR THEMSELVES



SMD was born as a strategic and tactical response to develop talent and support
for the medical device manufacturing.

Years of experience in the medical devices industry
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Completed Projects
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Students
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FROM OUR CLIENTS




EVELYN
MANUFACTURING ENGINEER

Course - Process Change Assessment

El curso fue dinámico y provechoso, considero que fue de gran aporte para la
elaboración de documentación en la empresa.


MARIANA
ENGINEER, SR PROCESS

Course - Process Change Assessment

Todo el curso estuvo muy bien explicado, con ejemplos y casos reales.


RAQUEL
ENGINEER II, MFG

Program - Fundamentals for the Medical Devices Industry (Introduction to Medical
Devices, ISO 13485, FDA 21 CFR 820)

Me ayudó a aclarar dudas y a refrescar conocimientos de la industria médica,
100% aplicables a mi puesto de trabajo.


ADRIANA
ENGINEER SR, SUPPLIER QUALITY

Program - Fundamentals for the Medical Devices Industry (Introduction to Medical
Devices, ISO 13485, FDA 21 CFR 820)

El curso fue excelente, el conocimiento que posee el profesor lo hace un
instructor de lujo.
El profesor tiene conocimiento en todas las áreas cubiertas, enseña con mucha
seguridad y con humildad.


WENDY
ENGINEER, SR SUPPLIER

Program - Fundamentals for the Medical Devices Industry (Introduction to Medical
Devices, ISO 13485, FDA 21 CFR 820)

Me encantaron los ejemplos. Creo que es muy útil el poder entrar y revisar las
normas y trabajar en "casos hipotéticos". También me gustó mucho tener
compañeros de diferentes background, porque enriquecen la discusión.


RICARDO
PRODUCTION MANAGER

Course - 21 CR 820 - FDA Quality System Regulation

Me parece que el curso tiene muy buenos ejemplos y ejercicios.


STEVEN
ENGINEERING CONSULTANT

Course - Process Validation (MVP, EQ, TMV, OQ, PQ)

En mi opinión el curso fue muy bueno, cumplió las expectativas y el profesor
siempre estuvo anuente a responder y aclarar todo lo necesario, además, tiene
mucho conocimiento sobre la industria lo cual es bueno.


CRISTOFER
MAINTENANCE TECHNICIAN

Course - Technician Development

Son clases interactivas, dinámicas y claras, de esta manera es claro el mensaje
y aprendizaje brindado.


GERARDO
 

Course - Applied Statistics in Medical Devices Manufacturing

Me gustó mucho el curso, los temas fueron adecuados, la dinámica final me
pareció enriquecedora al colocar ejemplos más reales y un análisis más
profundos.


ANDREIJ
QUALITY AND RELIABILITY TECHNICIAN

Program – Fundamentals for the Medical Devices Industry

Muy positivo los aportes basados en la experiencia del profesor, las historias
que ejemplifican los contenidos del curso fueron de mucho valor agregado.


MILDRED
MFG ENGINEER

Program – Fundamentals for the Medical Devices Industry

Excelentes clases. Me gusta que el profesor siempre va al punto con los
conceptos sin mucho rodeo. Eso facilita el aprendizaje y permite una mejor
asociación de los temas vistos con la resolución o prevención de los problemas
reales que uno se encuentra.
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We are a company with extensive experience in the medical device industry. Our
team shares a great passion for developing talent and improve the medical device
manufacturing.
Book an Appointment
Please call +506 8544 7000


NEWS



Alajuela, Costa Rica


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NAVIGATION


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CONTACT US


 * (506) 8544 7000
 * info@smdlearning.com


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