Medical Device Regulatory Expertise with Artificial Intelligence

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01

Course description

A practical course combining expertise in Brazilian medical device regulation with the use of Artificial Intelligence (Google Gemini) as an everyday regulatory copilot. Across two modules, participants progress from risk classification and notification of Class I and II products to registration, labelling and document auditing for Class III and IV products, applying AI to classification screening, application drafting, label review and dossier consistency analysis, always with critical validation.

02

Course objective

Equip participants to classify, notify and register medical devices with ANVISA based on RDC 751/2022 and RDC 429/2020, using Artificial Intelligence as a support tool to improve speed and quality while retaining technical review and traceability.

03

Course programme

40h of in-depth learning
  1. 01

    Module 1 - Classes I and II: Notification with AI (8h)

    Risk classification under RDC 751/2022 (general rules, criteria and borderline cases), notification versus registration and the Solicita/ANVISA workflow, and using Google Gemini for classification screening and application drafting, with critical validation.

  2. 02

    RDC 751/2022 risk classification: Classes I and II, criteria and borderline cases

  3. 03

    Notification versus registration: minimum documentation and the Solicita/ANVISA workflow

  4. 04

    AI for classification screening: prompt construction and Gemini-assisted classification

  5. 05

    AI for application drafting: assisted generation, critical review and validation good practice

  6. 06

    Module 2 - Classes III and IV: Registration and Labelling with AI (8h)

    Registration requirements for Class III and IV products (IEC 60601, ISO 10993, ISO 14971, GMP and MDSAP), labelling and IFU under RDC 429/2020, consistency analysis across documents and a dossier document audit workshop, all supported by AI.

  7. 07

    Class III and IV registration requirements: dossier, technical standards, GMP, MDSAP and common reasons for requests for further information

  8. 08

    Labelling and IFU with AI: RDC 429/2020 requirements and identifying nonconformities

  9. 09

    Cross-document consistency with AI: aligning labels, IFU and the dossier

  10. 10

    Document audit workshop: reviewing a Class III dossier with Gemini

04

Who can attend?

  • Regulatory Affairs and Quality Assurance professionals, Technical Managers, consultants and medical device manufacturer and importer teams seeking to incorporate Artificial Intelligence into their regulatory workflow.