Fri, Oct 23

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Zoom

Armed Course of Medical Device Dossier

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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Armed Course of Medical Device Dossier

Horario y ubicación

Oct 23, 2020, 9:00 AM – Oct 24, 2020, 12:00 PM

Zoom

Acerca del evento

Title         Assembling a Medical Device Dossier

Online Course Modality

Date         Friday 23 and Saturday 24-October-2020

Duration          6 hours

Schedule          9: 00-12: 00 hours

Speaker          QFB Azucena Justo Marcos

Zoom platform

cost 

$ 1500.00 (PER PERSON) VAT Included

It includes

  • Online course 6 hrs
  • Online speaker
  • Digital material
  • Diploma issued by REGULATE electronic
  • Constancy DC-3 (STyPS) 

Contents

  • 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.

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