Medical Device Clinical Investigation - ISO 14155 (ANVISA, FDA and CE)

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01

Course description

A course on conducting medical device clinical investigations under ISO 14155:2026, integrating the ethical and regulatory requirements of CEP/CONEP and ANVISA in Brazil, FDA IDE in the USA and MDR Annex XV in Europe, focusing on GCP and research participant protection.

02

Course objective

Equip professionals to plan, submit and conduct medical device clinical investigations in accordance with the main global regulatory frameworks, ensuring scientific integrity and participant safety.

03

Course programme

16h of in-depth learning
  1. 01

    ISO 14155:2026 and GCP fundamentals

  2. 02

    Study design and the Clinical Investigation Plan (CIP)

  3. 03

    Ethics approvals: CEP, CONEP and international equivalents

  4. 04

    ANVISA submissions, FDA IDE and MDR Annex XV

  5. 05

    Study conduct, monitoring and pharmacovigilance

  6. 06

    Reporting adverse events and deviations

  7. 07

    Clinical Investigation Report (CIR)

04

Who can attend?

  • Clinical Research, Regulatory Affairs and Medical Affairs professionals, study monitors, CROs and ethics teams involved in medical device clinical investigations.

Certification

HSC Global Certificate