Article 15 PRRC support
Independent Person Responsible for Regulatory Compliance support for qualifying manufacturers and authorised representatives under the EU MDR and IVDR.
Person Responsible for Regulatory Compliance
PRRC expertise integrated with your business.
Independent PRRC services for medical device and IVD organisations that need experienced, accessible regulatory oversight under the EU MDR and IVDR.
Continuous oversight—not a name on a document.
RHQC provides external PRRC support where the regulatory framework permits it, structured to keep the required expertise permanently and continuously at the organisation’s disposal.
The service is tailored to your products, organisation and quality system, with direct senior involvement and practical support across technical documentation, release, post-market surveillance and vigilance.
Device conformity oversight
Oversight that device conformity is appropriately checked in accordance with the quality management system before product release.
Technical documentation & declarations
Review and oversight to help ensure technical documentation and EU declarations of conformity are prepared, maintained and kept current.
Post-market surveillance
Oversight of post-market surveillance obligations, including plans, reports, trend review and the connection between post-market evidence and the QMS.
Vigilance responsibilities
Support for the timely assessment, escalation and reporting of serious incidents and field safety corrective actions.
Investigational devices
Where applicable, oversight of the required statement for investigational devices and alignment with the supporting regulatory documentation.
QMS integration
Clear integration of PRRC responsibilities into procedures, responsibilities, management review, change control, CAPA and regulatory decision-making.
Retained regulatory support
A practical ongoing relationship that keeps experienced regulatory oversight available as products, evidence, markets and obligations evolve.
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