WE ARE NIKAO

Your Regulatory & Manufacturing Staffing Partners
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We'll Help You Develop Your Life-Changing Technologies

We provide skilled engineers and auditors specializing in medical devices and in-vitro diagnostics to meet your manufacturing and regulatory requirements. Our team of highly skilled recruiters leverages their extensive experience to match your specific needs and criteria. We deliver quality candidates at competitive prices.

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Why Partner With Nikao?

Nikao understands the scope of our client’s projects. We provide resources with skill sets and experience levels that are congruent with your project’s demands. We can provide without limitation engineers, technicians, auditors and SMEs for remediation, process validations, regulatory affairs requirements, design and development, process improvement, lean manufacturing, CAPA, pFMEA development, audits, complaint handling, packaging validation, conformity, supplier audits,EU MDR audits, medical device cleaning validation, product transfer to another location or country, training office support, personal auditors, and risk management.

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Services

Your Regulatory & Manufacturing Partner.

We’ll Guide You From Concept to Market

Quality/Assurance Engineers

Manufacturing Engineers

Design Engineers

Regulatory/Compliance Engineers

Quality Auditors

Lead Auditors

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"OUR PROCESS IS VERY SIMPLE. PASSION LEADS TO YOUR IDEA, WE GUIDE YOU STEP-BY-STEP TO DEVELOP YOUR IDEA, OUR PARTNERSHIP LEADS TO YOUR SUCCESS!"

CEO – Nikao, Inc.

WE'LL HELP YOU LAUNCH YOUR
MEDICAL TECHNOLOGIES.

FDA & ISO REGISTERED REGULATORY & MANUFACTURING EXPERTS.

You will know what you are getting by hiring Nikao and you can feel confident that our knowledge and experience has immediate benefits.

– Consulting Firm dedicated to providing the best resources meeting all client parameters.
– Qualified and Certified Management Team
– Quality Driven and Cost Conscious Business Model.
– On time delivery and real time resource management.
– ISO Auditing Team

Nikao, Inc. is a leader in medical device, IVD and combination device quality, regulatory, and compliance services. Nikao is headquartered in one of the world’s fastest growing hubs for the medical device industry: Weston, Fl with medical device consultants throughout the United States. We consistently have provided comprehensive and audit ready regulatory strategies and solutions to companies of every size around the world, from start-up to Fortune 500.

"We position our clients for success with top-notch experience and knowledge and an enterprising culture that enables us to provide guidance in accord with the latest standards and regulations. Our mission is to lead your organization forward by providing a strong partnership based on trust, integrity and unmatched client focus. We will provide experience, knowledge, and guidance to meet your global quality and regulatory requirements while incorporating exceptional service, value and a balanced business approach. Through an extraordinary work ethic and industry best practices, our medical device consultants will consistently exceed your expectations in pursuit of your established goals. "

CEO – Nikao, Inc.
Team

We Have Helped Our Partners Launch Products That:

Provide Mobility for Wounded Soldiers, Provide Power to Our Military, Detect Skin Cancer, Deliver Stents to Hearts, Measure Your Vitals Wirelessly, Pinpoint & Quantify Your Pain, Sculpt Your Body, Resurface Your Skin, Save You Energy, Keep Your Children Safe, Connects Your Entire Home, Provide Real Time Data via Wi-Fi, Bluetooth and ZigBee, Decompress Your Spine, Provide Surge Protection & Power Conditioning For Your Entire Home, Reserve Your Parking Space From Your Home, Cools/Heats/Dehumidifies/Sanitizes Your Air and so much more.

SKIN CANCER DETECTION

FDA CLASS I, II & III DEVICES

ROBOTICS

PRIVATE LABEL

Team

The Highest Standards. The Happiest Clients.

MEDICAL. IVD.WEARABLES.IMPLANTABLES.
DISPOSABLES.REAGENTS.

Product Design, Product Development, Proof of Concept, Feasibility Studies, Rapid Prototyping, Manufacturing, Printed Circuit Board (PCB) Design & Assembly, 3D Design and Modeling, CNC Machining, Cable & Harness Assemblies, and much more.

Our Team

@ NIKAO.

Each completed project makes us even more motivated. Motivated for more designs, more projects,
and even some more pastelito’s. As a result, we feel proud to be a part of your success.

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Facility Square Footage

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Happy Clients…And Counting

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Quality Audits

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Pastelito’s Eaten

Our Team
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Get Connected.

We’d Love to Help! Ask Us Anything!

Let’s Talk About Your Projects

954.424.4554

Let’s Chat About Your Ideas

info@nikaousa.com

Visit Us @ Our Headquarters

1880 n commerce pkwy weston fl 33326

CALL: 954.424.4554

Copyright © 2022 Nikao.

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