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MedTech Regulatory & Quality Services

Structured, clarity‑driven pathways for global regulatory requirements and quality management systems across European and international operations.

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ISO 13485 Structure & Alignment

A resilient Quality Management System (QMS) is the foundation of every medical device organization.

McNett Strategy provides independent QMS consulting, ensuring that your operational processes meet the exacting requirements of ISO 13485 and align seamlessly with both European and international regulatory expectations.

  • Gap Analysis
    We assess your existing QMS against ISO 13485 and international expectations, identifying gaps that affect consistency, traceability, and compliance readiness.
  • Process Engineering
    We support organizations in evaluating and optimizing standard operating procedures (SOPs) for critical functions, including risk management (ISO 14971), post-market surveillance, and vigilance reporting.
  • Audit Preparation & Simulation
    We conduct targeted audit simulations to strengthen team readiness, surface vulnerabilities, and support corrective actions ahead of formal assessments.
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Navigating the EU MDR (2017/745)

We support medical device manufacturers in assessing, optimizing, and maintaining MDR technical documentation and regulatory strategies throughout the product lifecycle. Our services include technical documentation reviews, gap assessments, remediation recommendations, and readiness evaluations covering risk management, GSPR compliance, clinical evaluation, PMCF, PMS, vigilance, labeling, and post-market documentation.

What is required in EU MDR Technical Documentation?

The EU MDR requires Technical Documentation (TD) to be maintained for every device placed on the market. This includes detailed product descriptions, labeling and instructions for use, risk management files, design and manufacturing information, general safety and performance requirements (GSPR) checklists, and robust clinical evaluation reports.

How does the EUDAMED database affect manufacturers?

Manufacturers must register all new device models, including the Basic UDI-DI (Unique Device Identification), within the EUDAMED database before placing them on the EU market. Furthermore, operators must comply with ongoing transparency obligations, updating information promptly following any significant change. This is a mandatory requirement for market surveillance under the MDR.

Executive Regulatory Compliance Support: PRRC and Quality Oversight

The European Medical Device Regulation (EU MDR 2017/745) introduced enhanced governance requirements for medical device manufacturers, including the requirement to designate a Person Responsible for Regulatory Compliance (PRRC) in accordance with Article 15 MDR. Understanding the distinction between quality management responsibilities and regulatory compliance responsibilities is essential for maintaining an effective and compliant quality system.

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Understanding the Difference between QMR and PRRC

While quality management functions focus on maintaining and continuously improving the Quality Management System (QMS), the PRRC has specific responsibilities related to regulatory compliance under the MDR.

The PRRC is responsible for overseeing activities such as conformity verification, maintenance of technical documentation, post-market surveillance processes, and vigilance reporting requirements. Effective collaboration between quality and regulatory functions is critical to ensuring ongoing compliance throughout the product lifecycle.

Can an External PRRC be Appointed?

Yes. The MDR permits qualifying small and micro manufacturers to engage suitably qualified external regulatory professionals to fulfil Article 15 responsibilities. This approach enables organizations to access senior regulatory expertise and oversight while maintaining a lean operational structure and ensuring continued compliance throughout the product lifecycle.

McNett Strategy provides senior regulatory expertise to support manufacturers in meeting Article 15 MDR obligations and maintaining effective compliance systems. We assist organizations with technical documentation assessments, PMS and vigilance process reviews, regulatory governance, compliance gap remediation, and ongoing regulatory strategy to support sustainable market access and lifecycle compliance.

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