Post-Market Control and Medical Device Vigilance

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01

Course description

A course covering all medical device post-market surveillance obligations in Brazil (VIGIMED/NOTIVISA, medical device vigilance RDC) and their European (MDR PMS/PMCF) and US (FDA MDR/MedWatch) counterparts, including CAPA, trend analysis and the Periodic Safety Update Report (PSUR).

02

Course objective

Train professionals to structure and operate a robust post-market surveillance and medical device vigilance system, meeting ANVISA, FDA and MDR requirements simultaneously and turning field data into effective improvement and risk reduction actions.

03

Course programme

16h of in-depth learning
  1. 01

    Medical device vigilance in Brazil (NOTIVISA / VIGIMED)

  2. 02

    Adverse events, technical complaints and mandatory reporting

  3. 03

    Post-Market Surveillance (PMS) and PMCF under the MDR

  4. 04

    MDR/MedWatch under the FDA (21 CFR 803)

  5. 05

    Trend analysis and integration with ISO 14971

  6. 06

    Post-market CAPA and root cause analysis

  7. 07

    Periodic Safety Update Report (PSUR)

04

Who can attend?

  • Medical Device Vigilance, Regulatory Affairs and Quality professionals, Technical Managers, CAPA analysts and medical device risk managers.

Certification

HSC Global Certificate

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Instructor

Ana Carolina Paz

SQA Lead Auditor and International Regulatory Affairs Specialist with 20 years' experience. Holds a Master's degree in Health Surveillance and Lean Six Sigma certification.

International Regulatory Affairs Specialist and Quality Management System Auditor, with 20 years' experience in MDSAP, GMP and ISO auditing. Extensive expertise in international certifications and ANVISA inspections, with established experience implementing medical device vigilance and pharmacovigilance systems.

An MDSAP Lead Auditor certified by HSC Global (Exemplar Global), ISO 13485 Lead Auditor (BSI-IRCA) and ISO 14001 Lead Auditor. Her academic background includes a Master's degree in Health Surveillance from INCQS/Fiocruz (2016-2018), a specialisation in Health Legislation and Surveillance from UFRJ (2009-2010), degrees in Pharmacy from Universidade Gama Filho (2006-2008) and Biomedical Science from UNIRIO (2000-2005), and current Law studies at Estácio de Sá.

Certified as a Lean Six Sigma Black Belt by UNICAMP, she has experience with KFDA (Korea), China, FDA (United States), LATAM, CE Marking and MDR (Europe) regulations. Fluent in English with advanced Spanish, with a track record of MDSAP implementation in more than 12 projects and conducting 10 second-party MDSAP audits.