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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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ZH

ZHU Hong

PRRC — Person Responsible for Regulatory Compliance

The PRRC is the qualified individual a manufacturer or authorised representative must have on hand to ensure ongoing regulatory compliance.

View in glossary →

1 declared company affiliation

Source: EUDAMED

Public regulatory data · synced 2026-06-19

20%

ZHU Hong is a Person Responsible for Regulatory Compliance (PRRC) in the medical device industry. Currently affiliated with Saints Sages. Explore their full professional profile and affiliations on MD Atlas.

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  • Saints Sages

    PRRC — Person Responsible for Regulatory Compliance

    The PRRC is the qualified individual a manufacturer or authorised representative must have on hand to ensure ongoing regulatory compliance.

    View in glossary →
    1) Check the conformity of the devices in accordance with the quality management system under which the devices are manufactured before release; 2) draw up the technical documentation and the EU DOC and keep it up-to-date; 3) Fulfil the post-market surveillance obligations in accordance with Article 10(10); 4) Fulfil the reporting obligations referred to in Articles 87 to 91; 5) in the case of investigational devices, issue the statement referred to in Section 4.1 of Chapter II of Annex XV.
    Source: EUDAMED · non-removable
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