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.