Clinical Evaluation - ISO 14155:2026 (ANVISA, FDA and CE Mark)

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01

Course description

A course focused on Clinical Evaluation of medical devices based on ISO 14155:2026, integrating ANVISA, FDA and MDR 745/2017 (Annex XIV) requirements, covering the Clinical Evaluation Plan (CEP), Clinical Evaluation Report (CER), systematic literature searching and PMCF.

02

Course objective

Prepare participants to structure medical device clinical evaluation in accordance with global best practice, producing CEPs and CERs that can be defended before regulatory authorities and notified bodies.

03

Course programme

24h of in-depth learning
  1. 01

    ISO 14155:2026 principles applied to clinical evaluation

  2. 02

    Clinical Evaluation Plan (CEP)

  3. 03

    Systematic searching and critical appraisal of the literature

  4. 04

    Analysis of clinical data and equivalence

  5. 05

    Clinical Evaluation Report (CER)

  6. 06

    PMCF and integration with PMS

  7. 07

    ANVISA, FDA and MDR expectations

04

Who can attend?

  • Regulatory Affairs, Clinical Research, Medical Writing and Quality professionals, and consultants involved in medical device clinical evaluation.

Certification

HSC Global Certificate Recognised by Exemplar Global RTP

Internationally recognised in more than 30 countries by Exemplar Global, with independent validation of the professional's technical competence.

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Photo of Drª. Juliane Rossato PhD

Instructor

Drª. Juliane Rossato PhD

Biomedical scientist with a PhD in clinical and regulatory evaluation of medical devices. More than 15 years in clinical research and ANVISA submissions. Co-inventor of an international patent.

  • Biomedical scientist with a PhD in clinical and regulatory evaluation of medical devices
  • More than 15 years in clinical and preclinical research
  • Specialist in ANVISA submissions and projects involving stents, TAVI and nanotechnology
  • Co-inventor of an international patent and leader of FINEP/TECNOVA-RS projects
  • Expertise in ISO 14155:2020, MDR 2017/745 and RDC 848/2024
  • Clinical and biological evaluation Consultant and Instructor at HSC Global