About Us – Kōhola Consulting

Our story and commitment to excellence in just a few lines.

Robert Malone

Founder

Hi, I’m Robert Malone, and I’m genuinely passionate about helping companies navigate the exciting yet complex world of quality and regulatory compliance. Having over 30 years of hands-on experience, I’ve had the privilege of working alongside teams from agile start-ups to established industry leaders. I love rolling up my sleeves and diving into the nitty-gritty of crafting robust systems and building comprehensive Quality Management Systems that truly work for the teams that will be using them, while at the same time meet global regulatory requirements like the FDA QSR/QMSR, ISO 13485, MDSAP, and the EU-MDR. My goal at Kōhola Consulting is simple: to share my real-world experience to help you not just meet regulations, but to optimize your processes and achieve lasting operational excellence with confidence. Let’s work together to make quality a true asset for your business!

A Legacy of Innovation and Inspiration

At Kōhola Consulting, we are dedicated to empowering companies within the highly regulated medical device, pharmaceutical, and dietary supplement industries. Our unwavering commitment to innovation drives us to create unique and exceptional solutions for our clients.
Led by Robert Malone, an ASQ Certified Quality Manager and Auditor with over 25 years of hands-on experience, we bring a profound understanding of quality management and regulatory compliance.

We specialize in establishing and optimizing Quality Management Systems (QMS) for global markets, ensuring adherence to critical standards such as FDA QSR (21 CFR Parts 803, 806, & 820), ISO 13485:2016, MDSAP, and EU-MDR 2017/745. Our comprehensive services encompass all aspects of Design Controls, Corrective and Preventive Action (CAPA) systems, supplier qualification, and robust process/product validation programs.

Kōhola Consulting is built on a foundation of practical application and a commitment to tangible results. We excel in problem-solving and have a proven track record of innovative solutions—from developing sophisticated risk management processes and validating OTS software, to guiding successful FDA applications and dramatically streamlining document control (by 70%). We’ve successfully navigated complex FDA audits, often resulting in minimal observations, and have significantly improved operational efficiencies, such as reducing adverse event misidentification by 97%.

Our mission is to serve as your strategic partner, offering expert guidance and hands-on support to not only meet but exceed regulatory requirements. We help you build a compliant, efficient, and high-performing quality framework that transforms challenges into opportunities for sustained growth and market success.

The Kōhola Distinction: Side-by-Side Comparison

Feature	The Traditional Consultant	The Kōhola Architect
Primary Focus	The Paperwork: Checking boxes to satisfy an auditor.	The Health: Building a resilient foundation for the company’s mission.
Methodology	Transactional: Fixes the immediate gap and leaves.	Architectural: Rewrites the system using “Human Factors” and visual logic.
Leadership View	Instructional: Tells the team what to do for compliance.	Organizational: Uses The Advantage to align the “Principals” first.
Process Style	Document Debt: High-volume, text-heavy SOPs that are hard to follow.	Visual Blueprints: Lean, visual flowcharts designed for human adoption.
Audit Defense	Reactive: Stressful “fire-fighting” when the FDA arrives.	Proactive: The “10-Minute Rule” and a “Front Room/Back Room” protocol.
The “Why”	Risk Avoidance: Avoiding fines and 483s.	Mission Protection: Protecting the “Light” and the lives the device will save.
Philosophical Root	Technical Only: Operates purely within the limits of the regulation.	Integrated Wisdom: Blends 30 years of ASQ rigor with a “Systems Sage” perspective.

Learn about Our Approach

Why Choose Us:

Innovation

We continuously push the boundaries of creativity to deliver innovative solutions.

Expertise

Our team of seasoned professionals brings unmatched expertise to every project.

Collaboration

We thrive on partnerships and teamwork, fostering collaborative efforts that result in groundbreaking solutions.

Let’s Create Together

Connect with us to explore how we can make your vision a reality. Join us in shaping the future.

By clicking on the “Get Stated” button below, you’ll find that we’re asking for some specific and detailed information so we can make our first interaction with you as valuable and tailored as possible.

By clicking on the “Request My Rigor Scan” button below, we’ll be asking some questions related to your existing QMS and you’re assessment about your organizations readiness for change.

By understanding your specific needs upfront, Kōhola Consulting can come prepared to discuss solutions that genuinely align with your goals, ensuring our conversation is productive right from the start.

Take Our Rigor Scan

★★★★★

Exceptional service! Kōhola Consulting goes above and beyond. I couldn’t be happier with the results.

Michael Zamboura

Explore Our Creations

Dive into a visual journey showcasing our best works.