Quality is not an Act
IT IS A HABIT.
We Are Qualified.
FDA. ISO. CE. MDR. GSA. CGMP.
FDA
FDA QSR 21 CFR – Part 820 Certified.
ISO
ISO Certified..
cGMP
cGMP Certified.
CE
CE Registered.
MDR
European MDR 2017/745–ECC.
SIX SIGMA
Six Sigma Certified.
ISO Quality Auditors on Staff.
The manufacturing sector is an industry in, which quality and dependability is not a luxury, it’s key. To ensure the highest quality products are delivered to our clients, we have an FDA/ISO Quality Manager, Quality Assurance and Quality Control auditors on staff. Our primary goal is to maintain a robust quality system that stresses defect prevention, reduction of waste in the supply chain, and cost reduction.
Internal Quality Audits.
Nikao has an Internal Audit System established, which audits all key elements of our quality management system continuously. Our FDA & ISO processes are directed by our Quality Manager, and continuously verifies the effectiveness of our quality management system. Our facility is audited by the FDA, Dekra, U.S. Government, IDF, and SGS (the world’s leading certification, inspection, verification, and testing company).
Quality Planning.
Quality Planning is a vital component of our Quality Management Sytsem (QMS). Our Quality Plan is the basis that certifies quality from start to finish, from order placement to order fulfillment. At Nikao, we are committed to providing quality products and services. Our goal is to provide increased manufacturing profitability, improved product and process performance, minimizing variations and waste, and cost reduction.
Risk Management.
Minimizing the risks associated with a new and current product is, perhaps, our primary responsibility. Our risk management process is focused on cost reduction, and identifying hazards associated with implementation and execution. Nikao takes a risk-based approach to compliance that involves a detailed assessment of the revenue impact. Our goal is remediating risks that reduce costs, increase productivity, focuses on quality and reduces waste.
Lean Environment.
Nikao is dedicated to providing a solid commitment to quality and our supply chain throughout the development, production, and fulfillment process. Our goal is to improve quality and efficienies, increase profitability, eliminate process variations, and reduce waste. In order to accomplish these goals, Nikao uses various quality tools such as Lean, Six Sigma, 5S, Continuous Improvement, Just-In-Time, One Piece Flow, Root Cause Analysis, Kanbans, Value Stream Mapping, and other vital processes.
"In 2010, I joined Medical Technologies Unlimited (now Med-Tek, LLC) to provide operational guidance as they prepared to bring Version 2 of their proprietary patented technology “CMAP Pro” to market. At the time the CMAP Pro device was being engineered and manufactured in a generic electronics manufacturing warehouse in New Mexico – they were neither FDA or ISO compliant. I spent the next 60 days leading a national search for a medical device manufacturer that was ISO 13485, FDA and GMP compliant. After flying across the country vetting multiple manufacturing facilities it wasn’t until I met Edwin and toured his facility that I realized they were a perfect fit for our needs. Edwin and his team took a product that was extremely rough around the edges and created a final product that still holds its own today with respect to design and engineering. The commitment, professionalism, industry and regulatory knowledge Nikao provides is second to none. I will not hesitate to bring all future development and manufacturing projects to Nikao."
Our Certifications.
We are Qualified.
