Biological Evaluation Dossier - ISO 10993:2025 (ANVISA, FDA and CE Mark)

Request a quoteSpeak to our team

Next enrolment step

Choose your cohort

No cohorts are open at present. Contact the team about the next planned cohort.

01

Course description

A course integrating the updated requirements of the ISO 10993:2025 series with ANVISA, FDA and CE Mark regulatory expectations for structuring the Biological Evaluation Dossier, including the Biological Evaluation Plan (BEP) and Biological Evaluation Report (BER), focusing on a risk-based approach and minimising unnecessary testing.

02

Course objective

Equip participants to plan, document and defend medical device biological evaluation before regulatory authorities, applying the risk-based approach of ISO 10993-1:2025 and building a robust dossier recognised in major global markets.

03

Course programme

16h of in-depth learning
  1. 01

    Overview of the ISO 10993 series and 2025 updates

  2. 02

    Device categorisation by contact type and duration

  3. 03

    Biological Evaluation Plan (BEP) and gap analysis

  4. 04

    Chemical characterisation and toxicological assessment

  5. 05

    Reasoned selection of biological tests

  6. 06

    Biological Evaluation Report (BER)

  7. 07

    Specific ANVISA, FDA and CE Mark expectations

04

Who can attend?

  • R&D, Regulatory Affairs and Quality professionals, toxicologists, biomedical engineers and consultants involved in medical device biocompatibility 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.

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