Home > About us
Your Trusted Partner in Medical Device Contract ManufacturingSince 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 StoryBriteMED 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 Milestones2012
ISO-13485:2003certified
Core OEM/ODM services.
2016
TFDA
Medical Image Storage Device for Pulmonology (Class I )
2017
TFDA GMP certified
2018
ISO13485:2016 certified
2018
TFDA/CE/PMDA
12 Lead PC-Based Resting ECG –V1 (Class II)
2019
FDA QSR
2019-2021
TFDA/CE
Show more
FDA Contract manufacturing
Show more
2022
TFDA QMS certified
2023-2024
TFDA QMS certified
2023-2024
TFDA/CE
Show more
TFDA
Show more
FDA Contract manufacturing
Show more
2025
CE MDR QMS Approval
FDA QMSR Preparation
ISO 14064-1-GHG Inventory Report
ESG Practices
2025
TFDA Submission in progress
Show more
FDA Submission in progress
Show more
MDR Submission in progress
Show more
![]() Celebrate Humanity With Technology!
Regulatory Compliance and Certifications![]() |