Device Experience
Class I, II, & III
Class A, B & C
Supporting Healthcare’s Best Through
Innovation and Expertise
Naico is a team of medical device experts whose careers span 20+ years while serving the most recognized device companies in the world. Now our team is delivering this industry knowledge and regulatory experience to every company and product supported.
Regulatory Experience
US, Europe, Asia, &
Middle East
Certifications
ISO 13485, ISO 14971,
ISO 27001, & ISO 9001
Industry Expertise
Electrosurgical
Drug Delivery
Monitoring & Diagnostics Devices
SaMD
How We Help?
-
Modernize Existing Products
Obsolescence, Cost optimisation, From factor design,
FDA Compliance etc. -
Design & Development
POC, MVP, Prototype, Pilot
-
Ensure Regulatory Compliance
DHF, Design Verification and Validation
Services we offer
Software Development
Hardware Development
Design Verification and Validation
Quality Assurance and
Regulatory Affairs (QARA)
Product Risk Management
Our Customers
Dubai Hospital
EMED
Nova Oculus
Voximetry
Zona Health
iVinci Health
Opeeka
Our Partners
-
Regulatory partners to help with FDA approval 3x faster
-
Multiple areas of expertise sourced from experienced device partners
Are you ready to start your journey with Naico?
Lets Get in Touch!
Have a question or need assistance?
Reach out to us via email or phone. We're eager to assist you.
Naico ITS Inc. (USA)
533 Airport Blvd. No. 400, Burlingame, CA, US 94010
+1 778 350 3044
m.riyas@naicoits.com
Naico Tech Inc. (Canada)
26 Bastion Square, Victoria BC, Canada V8W 1H9
+1 778 350 3044
m.riyas@naicoits.com
Naico ITS Pvt. Ltd. (India)
O405B, SCK01, SmartCity, Kakkanad, Kerala, Pin: 682042
+91 9946 109 801 getinfo@naicoits.com 
