Fri, Mar 19
|Zoom
Medical Device Dossier Course
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.
Horario y ubicación
Mar 19, 2021, 9:00 AM – Mar 20, 2021, 12:00 PM
Zoom
Acerca del evento
Title Medical Device Dossier
Online Course Modality
Date Friday 19 and Saturday 20 March 2021
Duration 6 hours
Schedule 9: 00-12: 00 hours
Speaker QFB Azucena Justo Marcos
Zoom platform
cost
$ 1500.00 (PER PERSON) Taxes Included
It includes
- Online course 6 hours
- Online speaker
- Digital material
- Electronic diploma issued by REGULATE
- Constancy DC-3 (STyPS)
Temary
- Introduction
- Medical Device Dossier
-Legal documents
*Format
*Pay
* Legal accreditation
* Registration of establishment
* Notice of sanitary manager
* Label and counter label projects
*Certificate of Free Sale
* Certificate of Good Manufacturing Practices
* Maquila agreement
*Representation letter
* Letter of endorsement from the sanitary responsible
*General information
*Instructive
* Composition, description or diagram of the functional parts of the product
* Quali-quantitative formula
*Raw Materials
*Lab tests
*Fabrication process
*Sterilization
* Packaging information
* Product or analytical certificate
*Stability studies
* Biocompatibility tests
*Clinical studies
- Conclusions
GRADES
- The deadline to finalize your payment will be 5 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.