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.

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Device Experience

Class I, II, & III
Class A, B & C

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

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Services we offer

Software Development

Hardware Development

Design Verification and Validation

Quality Assurance and
Regulatory Affairs (QARA)

Product Risk Management

Our Customers

Our Partners

  • Regulatory partners to help with FDA approval 3x faster

  • Multiple areas of expertise sourced from experienced device partners

Lets Get in Touch!

Have a question or need assistance?
Reach out to us via email, phone, or the contact form above. We're eager to assist you.

Naico Inc. (USA)

533 Airport Blvd. No. 400,
Burlingame, CA, US, 94010

+1 778 350 3044 mohamed.riyas@naicoits.com


Naico Information Technology Services(P) Ltd (India)

Office No. O405B, 4th Floor, SCK 01,Smartcity (Kochi) SEZ, Kakkanad, Kochi, Kerala, Pin: 682042

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