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Your Trusted Partner in Medical Device Contract Manufacturing

Since its establishment in 2009, BriteMED has been dedicated to manufacturing medical electronic devices and developing electronic medical solutions to improve clinical workflows and enhance patient care. As an ISO 13485 and QMS certified medical device manufacturer, BriteMED specializes in professional medical device production, Quality Management Systems, medical device regulation, global regulatory affairs registration and certification, quality assurance and control, and supply chain management.

All BriteMED solutions are designed, tested, and refined based on clinical environments, featuring intuitive user interfaces and compliance with international regulations. BriteMED ensures that all solutions are highly reliable, easy to operate, and seamlessly integrated into healthcare applications, providing the optimal solution from concept to production.

Brand Story

BriteMED is a compound word that combines "Brite" and "MED". As a professional medical device manufacturing company, we aim to provide "medical" professionals and patients a "bright" life with technology-driven solutions. When observing the medical professionals who are fully occupied with their daily routine work in the hospital, our founder wonders if technology can help improve their quality of life and provide better treatment more efficiently. This is the reason for the establishment of BriteMED.

Over the years, BriteMED has continued to provide contract medical device manufacturing that helps streamline workflow and improve efficiency and applications in the clinical environment to enhance the quality of treatment. Driven by technology, we are committed to delivering flexible and optimal professional medical manufacturing solutions tailored to our clients' needs.

Company Milestones

2012
ISO-13485:2003 certified
Core OEM/ODM services.
2016
TFDA
Medical Image Storage Device for Pulmonology (Class I )
2017
TFDA GMP certified
  • Electrocardiograph
  • Cardiac Monitor, Oximeter, Noninvasive Blood Pressure Measurement System, and Electronic Thermometer
2018
ISO13485:2016 certified
2018
TFDA/CE/PMDA
12 Lead PC-Based Resting ECG –V1 (Class II)
2019
FDA QSR
2019-2021
TFDA/CE
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  • Multi-Parameter Patient Monitor (Class II)
  • 21.5 MMS Surgical Monitor (Class I)
  • 27 MMS Endoscope Monitor (Class I)
  • AIO endoscopy imaging system for Pulmonology (Class II)
 
FDA Contract manufacturing
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  • AIO endoscopy imaging system for Pulmonology (Class II)
2022
TFDA QMS certified
  • Electrocardiograph
  • Cardiac Monitor, Oximeter, Noninvasive Blood Pressure Measurement System, and Electronic Thermometer
  • Endoscope System and Accessories
2023-2024
TFDA QMS certified
  • Multifunctional Parameter Detector (Monitoring system of Glucose, Uric acid, and Total Cholesterol)
  • Medical Image Communication Device
  • Video Laryngoscope
2023-2024
TFDA/CE
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  • 12 Lead PC-Based Resting ECG-V2 (Class II)
  • AIO Display Monitor for ENT/Otorhinolaryngology (Class II)
  • AIO Endoscope Monitor for Urology (Class II)
  • Reusable Video Laryngoscope Adapter (Class I)
 
TFDA
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  • Patch ECG Recorder (Class II)
  • Multifunctional Spot Check Monitor (Class II)
 
FDA Contract manufacturing
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  • AIO Display Monitor for ENT/Otorhinolaryngology (Class II)
  • AIO Display Monitor for Urology (Class II)
2025
CE MDR QMS Approval
FDA QMSR Preparation
ISO 14064-1-GHG Inventory Report
ESG Practices
2025
TFDA Submission in progress
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  • Reusable Video Laryngoscope (Class I)
  • Bluetooth ECG (Class II)
 
FDA Submission in progress
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  • 12-Lead PC ECG (Class II)
  • Reusable Video Laryngoscope(Class I)
 
MDR Submission in progress
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  • Bluetooth ECG (Class II)
 
AboutBriteMED
Celebrate Humanity With Technology!

Regulatory Compliance and Certifications