Medical Device & Digital Health Consulting

Senior QA, RA & Compliance expertise —
fractional, when you need it most.

You need someone who can build, audit, and defend your quality system — not a team of consultants billing by the hour to learn your business. DWR Consulting gives you seasoned, exec-level regulatory and compliance leadership without the full-time cost.

Start a Conversation See What I Do

What I Do

The right expertise,
right-sized for your stage.

Whether you need ongoing compliance leadership or a focused project delivered and done, DWR brings the same level of rigor either way.

⚖️

Fractional QA / RA / Compliance

Embedded, ongoing compliance leadership on a retainer basis. I function as your QA, RA, and Compliance department — without the overhead of a full-time hire.

  • QMS ownership and maintenance
  • FDA and ISO 13485 readiness
  • HIPAA Privacy Officer support
  • Management Review and audit facilitation
  • Regulatory strategy and submission support
📋

QMS Builds & Project Work

Need a quality system built from scratch, or a specific deliverable completed and closed? I take on defined-scope projects with a clear output.

  • SOP and forms development
  • QMS gap assessments
  • Supplier qualification and audit programs
  • CAPA and nonconformance infrastructure
  • Pre-inspection readiness
📄

Regulatory Submissions & 510(k)

Strategic support for companies navigating the FDA clearance process, from predicate research through submission review.

  • 510(k) strategy and predicate analysis
  • Submission review and gap identification
  • Change control and post-market compliance
  • Multi-market regulatory planning (FDA, Health Canada, TGA)
🔒

HIPAA Compliance

Privacy and security compliance support for digital health companies and healthcare-adjacent organizations handling protected health information.

  • HIPAA Privacy and Security Rule gap analysis
  • Policy and procedure development
  • Incident response and breach assessment
  • Business Associate Agreement review
15+
Years in quality, regulatory,
and compliance leadership
3
Regulatory markets — FDA,
Health Canada, TGA Australia
1
Person. All of it. Built solo.
Kimberley Griffith, Founder of DWR Compliance Consulting

About DWR

Built by someone who has done the work — all of it.

DWR Consulting was founded by Kimberley Griffith, a compliance and regulatory executive who has served as the sole QA, RA, Compliance, and HIPAA Privacy Officer at a publicly traded medical device company — building the entire quality management infrastructure from the ground up while reporting directly to the CEO.

That means I know what it looks like when there is no team, no playbook, and no margin for error. I know how to write lean, defensible documentation that meets what FDA and ISO actually require — not what a consultant padding hours would add. And I know how to make compliance work for an early-stage company, not against it.

On the name: DWR stands for Dakota, Wyatt, and Reese — the three people who make everything worth doing. Named for them. Built for you.

Who I Work With

You might be a good fit if…

You're a medical device startup

Pre-market or early commercial stage, navigating FDA 21 CFR Part 820 / QMSR, ISO 13485, and your first 510(k) — without a full QA team yet.

You're a digital health company

Handling PHI and needing real HIPAA infrastructure — not just a checkbox policy. Or you're a SaaS company entering the healthcare space for the first time.

You have a gap to close

Post-inspection, post-audit, or pre-launch — you know something needs to be fixed or built, and you need someone who can come in and actually do it.

You need exec-level, not entry-level

You don't need someone to be managed. You need someone who can own the function, make the calls, and give you back time and confidence.

Get in Touch

Let's talk about what you need.

No intake form, no sales call. Just a direct conversation about where you are, where you need to be, and whether DWR is the right fit.

info@dwrcompliance.com

Based in the US · Available remotely · dwrcompliance.com