Clarity in Complexity

Global Regulatory & Quality Consulting
for MedTech

We build structured, effective Quality Management Systems and turn regulatory complexity into clear, coordinated actions that keep teams aligned and projects moving.

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Securing and Sustaining Your Global Market presence

Regulatory & Quality Management Compliance with Absolute Clarity

The global regulatory landscape continues to evolve, and manufacturers are expected to maintain well‑structured quality systems, clear documentation, and reliable post‑market processes across diverse markets. In this environment, clarity becomes a strategic asset.

At McNett Strategy, we support organizations in building regulatory and quality management practices that are coherent, transparent, and aligned with the frameworks that govern their products.

Our focus is on strengthening collaboration between engineering, quality, and operational teams so that compliance becomes an integrated part of how your organization works.
Our approach is grounded in precision, structured thinking, and practical understanding of how regulatory expectations translate into day‑to‑day processes. The result is an organization that operates with confidence and long‑term resilience — without overstatement, shortcuts, or unnecessary complexity.

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Illuminating Innovation

Regulatory and quality expectations can be complex across global markets. We turn them into clear, structured pathways that support product development and lifecycle management. Our focus is on clarity, enabling teams to make confident decisions at every stage.

Uniting Minds & Mandates

Compliance succeeds when people and processes move in the same direction. We bridge the gap between regulatory requirements and human execution — ensuring your teams understand not only what must be done, but why it matters.

Fierce Authenticity

In a high‑stakes industry, honesty is a strategic advantage. We provide unvarnished analysis, realistic pathways, and a boutique partnership built on trust, discretion, and technical depth.

our CORE Services

Specialized MedTech Consulting Services

Services
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Quality Management Systems (ISO 13485)

Building and refining Quality Management Systems that fit your organization.

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Regulatory Compliance Strategy

Supporting teams in interpreting global regulatory expectations and translating them into clear, workable structures, aligned documentation, and reliable post‑market routines.

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PRRC Advisory & Quality Governance

Supporting manufacturers with Article 15 MDR compliance, regulatory oversight, and governance frameworks through PRRC advisory services, quality management guidance, and compliance readiness assessments.

WHAT WILL YOU ACHIEVE?

Why MedTech Leaders Choose a Boutique Approach

We work exclusively in the medical technology sector, bringing focused expertise shaped by years across regulatory, quality, and organizational environments. As a boutique firm, McNett Strategy integrates seamlessly with internal teams and provides senior‑level engagement throughout every collaboration.

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Much of our work is grounded in a simple truth: most operational friction arises from misalignment — between people, expectations, and the processes that connect them. Drawing on a deep understanding of how teams, cultures, and organizations function, we approach compliance as a people‑driven discipline. It is not only about documentation; it is about creating shared understanding.

By aligning personnel with operational and regulatory expectations, we reduce complexity and support smoother decision‑making. We translate dense regulatory language into clear, actionable guidance that helps engineering, quality, and operational teams move in the same direction with confidence and clarity.

Unvarnished truths for medical device manufacturers

EU MDR & PRRC Compliance: Medical Device Regulatory FAQs

The European regulatory landscape is unforgiving, and generic advice is a liability. At McNett Strategy, our core philosophy is creating clarity in complexity. Below, you will find direct, actionable answers regarding EU MDR mandates, external PRRC eligibility, and critical EUDAMED registration deadlines.

Yes, provided your company qualifies as a micro or small enterprise (SME). Under Article 15 of the EU MDR, SMEs are permitted to outsource this legally mandated role to an external consultant. The external PRRC must possess specific formal qualifications in a relevant scientific discipline or regulatory affairs, and must be permanently available and integrated into your organization’s quality management processes. Recent 2026 regulatory revisions have further clarified that this external expert needs to be demonstrably „available“ rather than continuously present on-site.

While a QMR focuses on the operational implementation and continuous improvement of your Quality Management System (QMS) under ISO 13485, the PRRC is a specific, legally mandated role introduced by the EU MDR. The PRRC carries strict personal and corporate liability for regulatory adherence, including checking device conformity prior to batch release, maintaining technical documentation, and overseeing post-market surveillance and vigilance reporting. Essentially, the QMR manages the quality processes, while the PRRC holds the regulatory liability.

No. While non-EU manufacturers are legally required to appoint a European Authorized Representative (EC REP) who must have continuous access to their own PRRC, these roles must remain separate. To avoid conflicts of interest and ensure independent regulatory oversight, the PRRC acting on behalf of the Authorized Representative cannot be the exact same individual acting as the PRRC for the non-EU manufacturer.

The transition period ends and EUDAMED usage becomes mandatory for manufacturers on May 28, 2026. By this deadline, all economic operators must be registered to obtain a Single Registration Number (SRN). Furthermore, manufacturers must register all new device models, including the Basic UDI-DI (Unique Device Identification) and relevant conformity assessment information, directly into the database before placing the devices on the European market.

About US

Bridging The Critical Gap With Medical Device Consulting

McNett Strategy provides clarity‑driven regulatory and quality guidance for the medical technology sector. We focus on aligning processes, responsibilities, and expectations so organizations can operate with confidence and stability.
By strengthening communication and supporting practical system development, we help teams navigate complex environments with clarity and purpose.

Audit failures rarely stem from technical gaps—they result from a misalignment between human teams and rigid quality systems. Our mission is to eliminate this operational friction by bringing absolute clarity to regulatory complexity.“

— Cretia McNett, Founder

About Us
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Clarity Starts Here

Specialized regulatory quality guidance for organizations navigating complex requirements.

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