Preclinical Design Evaluation

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01

Course description

A structured course on conducting Preclinical Evaluation of medical devices, integrating physical, chemical, mechanical and biological characterisation, risk analysis (ISO 14971) and a reasoned justification for testing, aligned with ANVISA, FDA and European notified body expectations.

02

Course objective

Equip participants to plan, conduct and document the preclinical evaluation of medical devices, minimising unnecessary testing and building a sound technical justification for global regulatory submissions.

03

Course programme

16h of in-depth learning
  1. 01

    Scope and objective of preclinical evaluation

  2. 02

    Physical, chemical and mechanical characterisation

  3. 03

    Bench testing and simulated use

  4. 04

    Integrated biological evaluation (ISO 10993)

  5. 05

    Test plan and reasoned justification

  6. 06

    Preclinical evaluation report

  7. 07

    ANVISA, FDA and MDR expectations

04

Who can attend?

  • R&D, Engineering, Quality and Regulatory Affairs professionals, consultants and laboratories working on medical device development and characterisation.

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.

Exemplar Global RTP seal
Photo of Drª. Juliane Rossato

Instructor

Drª. Juliane Rossato

  • Dr 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