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    Regulatory Affairs Professionals Society

    Global professional society for regulatory affairs across health-product industries.

    Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 2026

    Definition

    RAPS is the largest global organization for regulatory affairs professionals across pharmaceuticals, medical devices, IVDs, biologics, and digital health. Administers the Regulatory Affairs Certification (RAC) credential.
    What the regulation says
    While not a regulatory body itself, the Regulatory Affairs Professionals Society (RAPS) significantly influences regulatory best practices. Regulatory agencies often engage with RAPS through various forums, acknowledging its role in professional development and dissemination of regulatory knowledge, which indirectly supports compliance with regulations like the FDA's 21 CFR Part 820 (Quality System Regulation) and the EU MDR (Regulation (EU) 2017/745).

    What this means in practice

    RAC certification is a common professional standard for MedTech regulatory staff. RAPS conferences and publications are widely used for ongoing FDA/EU MDR/global regulatory updates.

    Examples

    • A regulatory affairs specialist preparing for an FDA audit uses RAPS resources to understand the latest interpretations of 21 CFR Part 820.
    • A startup MedTech company encourages its regulatory team to obtain RAC certification to enhance their understanding of EU MDR requirements.
    • A quality engineer attends a RAPS conference to learn about emerging cybersecurity regulations impacting medical devices and digital health.
    Common pitfalls
    • •Assuming RAPS guidance is mandatory regulation, as RAPS is a professional organization and not a regulatory authority.
    • •Failing to supplement RAPS resources with direct study of official regulatory texts and guidance documents.
    • •Believing that RAC certification alone guarantees regulatory compliance without continuous professional development and practical application of knowledge.
    • •Underestimating the value of networking within RAPS for understanding diverse interpretations and industry trends.

    Frequently asked questions

    RAPS is dedicated to supporting regulatory professionals and advancing the regulatory profession, primarily in healthcare product sectors like medical devices, pharmaceuticals, and biotechnology. It provides education, networking opportunities, and professional development resources.
    Grouped by theme

    Primary references

    3 sources
    Link health: 3 verified· last checked 2026-06-20
    RAPS·1AAMI·1AdvaMed·1
    1. 1
      RAPS
      Verified
      RAPSraps.org
    2. 2
      AAMI
      Verified
      AAMIaami.org
    3. 3
      AdvaMed
      Verified
      AdvaMedadvamed.org

    Inline markers like [1] jump to the matching reference above.