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SetuMed

Consultancy

www.setumed.eu/enMünchen, Germany

About

SetuMed is a regulatory consulting company founded and led by Dr. Pawandeep Kaur Bollinger, PhD, a certified Person Responsible for Regulatory Compliance (PRRC). The name blends "Setu" (Sanskrit for "bridge") and "Med" (medicine), reflecting the company's mission: bridging the gap between regulatory compliance and market access for medical devices and pharmaceutical products. It is based in Germany and is a member of EMWA (European Medical Writers Association). SetuMed targets medical device manufacturers, pharmaceutical companies, and SMEs, particularly those navigating the EU MDR (Medical Device Regulation) transition deadline of 2027–2028 and evolving EMA regulations.

Representatives

Founder

SetuMed

Marketplace (1)

  • Project cooperation

    GCP Comply – ISO 14155:2026 Clinical Compliance Platform seeking consortium for IND-03

    SetuMed's GCP Comply is a digital compliance workspace for medical device trials (ISO 14155:2026). We seek academic, regulatory & clinical partners for HORIZON-HLTH-2026-01-IND-03 to advance regulatory science for patient-centred health technologies.

    • Consortium/Coordinator seeks Partners
    • Partner seeks Consortium/Coordinator
    • DESTINATION 6: HORIZON-HLTH-2026-01-IND-03: Regulatory science to support translational development of patient-centred health technologies
    • DESTINATION 5: HORIZON-HLTH-2026-01-TOOL-06: Support to European Research Area (ERA) action on accelerating New Approach Methodologies (NAMs) to advance biomedical research and testing of medicinal products and medical devices
    Author

    Founder at SetuMed

    München, Germany