About

As a rising star in global medical device sector, Medimaging Integrated Solution Inc. (MiiS) is a trusted partner of Hospitals, Medical Schools, and Health Organizations, providing worldwide practitioners with first-class digital and portable diagnostic solutions.


Since its establishment, MiiS has been involved in the design and manufacturing of digital hand-held diagnostic scopes that meet the highest quality standard in the world. In addition, the Company produces auxiliary tools to enhance effectiveness and efficiency of healthcare practice.

History

2010

Originated from the incubation center at the National Chiao Tung University (NCTU), Taiwan, MiiS started its business primarily based on the foundation of innovation.

2011

Established a medical equipment assembly factory "RD2".
Obtained ISO13485 quality system certificate.

2012

Factory "RD2" obtained TFDA GMP registration letter.
Obtained the first TFDA Class II certificate of eye fundus camera.
Obtained the first 510K letter of eye fundus camera, and obtained 510k letter of slip lamp and tonometer in the coming years.
Obtained the first CE MDD Class II certificate of eye fundus camera.

2013

Passed the Japan GMP audit.
Passed the KFDA GMP audit.

2014

Passed the first FDA QSR audit for eye fundus camera.
Obtained the first CFDA (NMPA) Class II certificate of eye fundus camera.

2018

Passed the first FDA QSR audit for digital hand-held slit lamp.
Established a medical equipment assembly factory "IE4".

2019

Factory "IE4" obtained TFDA GMP registration letter.
Selected and participated in Bayer Taiwan G4A X H.Spectrum Innovation Program

2020

Established Factory "IE4-2" for the manufacturing of micro camera module.

2021

Emerging Stock Board Registration
Got the opinion letter for science and technology business issued by MOEA-IDB

2022

IPO at TSE (Taiwan Stock Exchange)
Obtained the TFDA Class II Certificate (Nasopharyngoscope)
Obtained the EU CE Certificate (Digital Otoscope)
Obtained the FDA 510K Certificate (Nasopharyngoscope)

2023

Obtained the EU CE Certificate (Smart Wound Carer)
Obtained the Thai FDA Certificate (Optical Coherence Tomography)
Obtained the Japan PMDA Class II Certificate (Nasopharyngoscope)

Vision and Strategy

The products of the Company, namely Horus Scope, address unique problems related to healthcare and emerging technology to have a positive impact on the medical world. The solutions provided by the Company have to meet an absolute Quality standard, including but not limited to ISO 13485, 9001, FDA, and CE mark. Achieving and maintaining leadership requires that all MiiS operations work together to consistently bring value to worldwide customers with the following capabilities:

Technology

Processes

Customer and Market
Understanding

Industry Skills
and Experience

Looking forward, MiiS will strive to extend these strengths and share the fruits of its ongoing investments to deliver long term profitable growth. The goal is to ensure that Horus Scope stays at the forefront of technological innovation and exceeds customer expectations while rewarding employees for their dedication and high performance.

Awards

Taiwan Excellence Award

2017 Fundus Camera (DEC 200 ) Gold Award
2018 Diagnostic Control Unit (DSC 200P)
2019 Oral Camera (UOC 100)
2020 Tonometer (DPT 100)
2021 Eye Anterior Camera (DEA 200/DEA 200P) Gold Award
2022 Smart Wound Carer (MPD 100)
2023 AI-assisted Diagnostic Device for Diabetic Retinopathy (AI-DR+DIB 100) Gold Award
2024 Disposable Nasopharyngoscope (EES 100)

Taiwan BIO Awards

2023 Innovation of the Year

INPEX (USA)

2017 Invention and New Product Exposition Gold Award Total solution of digital medical scope products

Taipei Biotech Awards

2017 Innovation Gold Award Horus Digital Fundus Camera DEC 200
2018 Go-Global Awards - Silver Medal Award

iF Design Award

iF Design Award 2021 Device with AI computing for diabetic retinopathy (DIB 100+DEC 200+DSC 300)
Certifications

MiiS has acquired the following certifications:


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