Designed for organizations that have a quality management foundation in place and need structured expert guidance to implement it with discipline, defensibility, and regulatory intent — not just good intentions.

This is not a document delivery service. This is a 30-day advisory engagement focused on architecture, process integration, and implementation rigor. You will work directly with an experienced medical device regulatory consultant across four structured weekly sessions, with ongoing support between sessions, to build a QMS that is genuinely audit-ready — not just technically complete.

Who This Is For

This engagement is built for quality and regulatory teams who are serious about implementation. It is equally suited to organizations establishing QMS infrastructure for the first time, teams remediating gaps identified in an FDA inspection or notified body audit, and companies preparing for a 510(k) submission, CE marking, or investor due diligence where QMS defensibility is under scrutiny.

Organizations that have established a foundational QMS document system will get the most out of this engagement. If you do not yet have a structured documentation foundation in place, our AI-Accelerated QMS Systems [link to QMS products] are the recommended starting point before beginning this advisory.

Engagement Structure

Duration: 30 calendar days from onboarding call.

Onboarding Session: 60-minute kickoff and system assessment to establish baseline, align objectives, and map the engagement to your specific regulatory context and implementation priorities.

Weekly Advisory Sessions: Four structured sessions of 60–90 minutes each, organized around a progressive implementation framework designed to build momentum and accountability across the full 30 days.

Email Support: Ongoing clarification and guidance between sessions to keep implementation moving without waiting for the next call.

Written Deliverables: Structured milestone summary and prioritized next-step implementation plan delivered at engagement close.

How It Works

Week 1 — System Assessment & Architecture Review We begin with a thorough review of your current QMS structure, document hierarchy, and risk integration posture. By the end of week one you will have a clear picture of your baseline, your most significant gaps, and the implementation priorities that will drive the remaining three weeks.

Week 2 — Process Integration & Gap Prioritization We align your procedures with ISO 13485 requirements and IEC 62304 software lifecycle controls where applicable, define your corrective priorities, and begin integrating your processes into a coherent, traceable system rather than a collection of standalone documents.

Week 3 — Implementation Calibration We refine your change control, design controls, traceability framework, and documentation flow — making sure the system works in practice, not just on paper. This is where most QMS implementations break down, and where structured advisory guidance has the highest impact.

Week 4 — Readiness & Control Review We conduct a final review of your QMS structure, governance alignment, and regulator-facing defensibility. You will leave week four with a system you can stand behind in front of an FDA investigator, a notified body auditor, or an investor's due diligence team.

What You Walk Away With

At the close of the engagement you will have a QMS that is architecturally sound, process-integrated, and defensible under regulatory scrutiny — along with a written milestone summary documenting what was built, what was refined, and the prioritized next steps for ongoing maintenance and continuous improvement.

More importantly, your team will understand the system — how it works, why it is structured the way it is, and how to maintain it going forward. That operational confidence is what separates a QMS that survives an audit from one that falls apart under questioning.

What This Is Not

This engagement is not a full outsourced QMS development service, submission support, or regulatory strategy consulting. It is a structured advisory designed to guide your team through implementation with expert oversight. The work is collaborative — you build it, we make sure you build it right.

If your needs extend beyond guided implementation, please contact us for a service that may be a better fit.