Expert consulting for medtech success—streamlined, scalable, and compliant.
Transforming Innovation into Impactful Solutions.
Expert consulting for medtech success—streamlined, scalable, and compliant.
About Kuha Consulting
Our Mission
Our mission at Kuha Consulting is to empower medical device and technology innovators to transform ideas into impactful solutions by providing expert guidance in 510k testing, process validations, validation documentation, manufacturing validation and supplier relations. We are committed to enabling businesses to deliver safe, effective, and high-quality medical devices to global markets efficiently and sustainably.
Engineering Consulting Services
Overview
At Kuha Consulting, we bring over a decade of hands-on experience in the medical device and medtech industry, backed by a strong foundation in Biosystems Engineering and Biomedical Engineering. Our expertise spans key areas of the product lifecycle, including 510k testing, process validations, manufacturing optimization, and supplier relations.
With a proven track record working with startups for medical device consulting and global leaders like Edwards Lifesciences, Becton-Dickenson and Johnson & Johnson, Kuha Consulting specializes in helping medical device companies streamline operations, execute manufacturing validation, scale production, and meet FDA compliance through 510k testing.
Our mission is to empower innovators to deliver impactful solutions to global markets, combining technical expertise with a deep understanding of the unique challenges in the medical device sector. At Kuha Consulting, we are dedicated to turning your vision into reality with precision and efficiency.
Visit the Projects & Experiences page to see real projects brought to life with the support of Kuha Consulting expertise.
510k Testing for FDA Clearance
We guide medical device companies through the intricate requirements of 510k testing, ensuring your products meet the necessary standards for safety and effectiveness. From understanding regulatory pathways to preparing test protocols, we streamline the process to minimize delays and ensure compliance.
Process Validations
We specialize in developing and executing 510k testing as well as robust process and manufacturing validation strategies, including defining requirements for manufacturing equipment, creating manufacturing validation plans, IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification). Our services ensure that your manufacturing processes are consistent, repeatable, and compliant with industry standards.
Manufacturing Optimization and Scaling
We optimize manufacturing processes to reduce costs, improve efficiency, and scale production effectively. Whether transitioning from prototype to full production or refining existing processes, we provide actionable solutions tailored to your business needs.
Supplier/Contract Manufacturer Management
We enhance supply chain performance by evaluating and optimizing supplier relationships, ensuring quality, reliability, and cost-effectiveness. Our approach ensures that your supply chain supports seamless manufacturing and mitigates risks.
About Kuha Consulting
Our Vision
At Kuha Incorporated, our vision is to be the premier partner for MedTech innovators, driving transformative advancements in healthcare by fostering excellence in manufacturing, testing, and supplier relations. We strive to create a future where every innovation is seamlessly brought to market, delivering safe, effective, and life-changing devices to patients worldwide.
Our Services
We provide expert medical device consulting services designed to help MedTech companies bring their innovations to market with efficiency, quality, and confidence. Our specialized offerings include:
- 510k Testing: Comprehensive guidance through 510k testing requirements to ensure your devices meet the highest safety and effectiveness standards to achieve FDA clearance.
- Process Validations: Expertise in developing and executing manufacturing validation (IQ, OQ, PQ, TMV) to establish consistent, reliable manufacturing processes.
- Manufacturing Optimization and Scaling: Tailored solutions to streamline your operations, reduce costs, and scale production effectively from prototype to full commercialization.
- Supplier Relations: Strengthening supplier partnerships and ensuring quality, reliability, and alignment with your operational goals.