Fri, Jun 25

|

Zoom

Online Course Dossier of Medical Devices

At the end of the course, the assistant will be able to identify the critical points of the dossier of a medical device, managing to identify the most frequent errors through real practical cases.

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Online Course Dossier of Medical Devices

Horario y ubicación

Jun 25, 2021, 9:00 AM – 12:00 PM CDT

Zoom

Acerca del evento

Title              Medical Device Dossier

Modality       Online course

Date             Friday 25 and Saturday 26 June 2021

Duration          6 hours

Schedule           9: 00-12: 00 hours

Speaker          QFB Azucena Justo Marcos

Platform       Zoom

cost

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$ 1,500.00 (PER PERSON) Taxes Included

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It includes

  • Course       Online 6 hours
  • Speaker       online
  • Material       digital
  • Diploma       electronic issued by REGULATE
  • Constancy       DC-3 (STyPS)

TEMARY

  • Introduction
  • Dossier  Medical Device

     - Application Form and Payment of Rights

     - Accreditation of legal representative

     - Notice of Operation and Health Responsible

     - Label or counter label projects

     - Free sale certification

     - Certificate of Good Manufacturing Practices of the establishment

     - Maquila agreement

     - Representation letter

     - Declaration of endorsement by the Health Responsible for

     - General information

     - Instructions for use, insert or operating manual or leaflet

     - Composition, description, or diagram of the functional parts of the product

     - Declaration of the qualitative formula per unit of measure, dose or percentage for formulated products

     - Raw Materials

     - Lab tests

     -  Manufacturing process information

     - Sterilization

     - Packaging information

     - Analytical certificate or product certificate

     - Stability studies

     - Biocompatibility tests

     - Clinical studies

8. Attention to the procedure: Check-List, Format, Homoclaves.

9. Approval times

10. Causes for not granting the Sanitary Registry

11. Conclusions

GRADES

  • The deadline to finalize your payment will be 3 days before the event.
  • DO NOT REGISTER IF YOU ARE NOT SURE TO TAKE THE ONLINE COURSE SINCE YOU WILL BE MAKING THE OPPORTUNITY FROM ANOTHER INTERESTED PERSON.
  • At the end of your registration, our REGULATE team will send you a registration confirmation email and the payment information will be sent.

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