EU MDR & IVDR QMS Integration & PRRC

Regulatory compliance cannot be sustained through technical documentation alone. NKB Regovanta reviews how MDR/IVDR obligations are embedded into the manufacturer’s quality system so that procedures, records and implementation remain aligned with the certified device and its lifecycle.

Align Your QMS with MDR / IVDR

13 Core QMS Areas We Assess

Design and development controls & Design History File (DHF)

Risk management integration aligned with ISO 14971

Supplier and outsourced-process control & critical supplier audits

Verification, validation and manufacturing process validation

Clinical evaluation / performance evaluation governance

PMS, PMCF / PMPF and vigilance reporting procedures

Complaint handling and trend reporting systems

CAPA and nonconformity management

Change control and Notified Body notification triggers

Document and record control across device lifecycles

Training, competence and regulatory qualification records

Internal audit and management review governance

Regulatory data, UDI and EUDAMED registration controls

PRRC & Regulatory Governance (Article 15)

Where applicable, we review how Person Responsible for Regulatory Compliance (PRRC) responsibilities interface with batch release, technical documentation maintenance, PMS/vigilance and lifecycle compliance. The objective is clear accountability, demonstrable qualification records, and uncompromised regulatory oversight.

Expert Differentiator

Implementation Testing Over Paper Checklists

A compliant technical file cannot compensate for weak implementation. We test whether the QMS can produce objective evidence that the regulatory strategy is actually being executed on the manufacturing floor and in post-market surveillance.

Audit Readiness Scope

• ISO 13485:2016 + MDR/IVDR Gap Analysis

• Mock Notified Body Stage 1 & Stage 2 Audits

• Critical Subcontractor & Supplier Audits

• CAPA Remediation & Root-Cause Resolution

Prepare for QMS Audit

Ensure your quality management system produces defensible objective evidence before Notified Body inspectors arrive.

Schedule QMS Audit

Harmonize Your Quality System with European Regulatory Mandates

Connect your procedures, PRRC responsibilities, and technical files into one seamless audit-ready infrastructure.

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