BrosMed Medical is more than just a company; we are leading the medical device design and manufacturing revolution. To make it simpler, to make it better, to make it more cost efficient, and to make it with excellent quality. To expand treatment options for clinicians by overcoming traditional barriers. To enhance patient freedom and fulfillment.
“Inventing a movement, improving lives and inspiring everyone (invent, improve and inspire).”
We are not working alone. Part of our success has come through working closely with customers, patients, industry and institute partners, and government leaders and agencies to realize the vision of better, simpler and more accessible healthcare.
Our ultimate purpose is to improve the lives of patients, and our approach is already resulting in changed lives and industry improvements. Together, we’re changing traditional perceptions of how health care can be delivered.
BrosMed Medical develops, manufactures and markets medical devices primarily used by interventional cardiologists, radiologists and vascular surgeons in angioplasty procedures and other minimal invasive devices.
We provide solutions to our customers through innovative design, effective supply chain management, world-class manufacturing, and flexible channels of distribution and through the development or acquisition of innovative technologies.
BrosMed has adopted a One Stop Facility concept to meet all our customers’ needs.
The facility is located in the 15th building of the SME’s Venture Park, in the Dongguan SSL Hi-Tech Industrial Development Zone, Guangdong Province, China. The facility is 30,000 square feet (or 3,000 square meters) with Class 7 clean-room (Class 10,000), microbiology lab, products characteristic lab and EtO sterilization chamber.
The facility is designed and constructed based upon the latest Good Manufacturing Practice (GMP) requirements by CFDA and related international standards.
BrosMed continuously strives to meet the accepted standards for quality control and regulatory compliance:
- ISO 13485：2016, Medical devices — Quality management systems — Requirements for regulatory purposes
BrosMed Quality System also complies with, but is not limited to:
- 93/42/EEC: Official Journal of the European Communities 93/42/EEC of 14 June 1993 concerning medical devices (“The Medical Devices Directive”)
- Quality System Regulation (QSR), 21 CFR 820
- Investigation Device Exemptions (IDE), 21 CFR 812
- Premarket Notification, 510(k), 21 CFR 807
- Quality Management Standards for Medical Devices, CFDA Order No.64 Publicized as of Dec 29, 2014
- Provision for Medical Device Registration, CFDA Order No. 4 Publicized as of Oct 01, 2014
- Provision for Medical Device Product Standard, CFDA Order No. 33 Publicized as of Apr 26, 2017
- Provision for Medical Device Classification, CFDA Order No. 15 Publicized as of July 14, 2015
- Provision for Instructions for Use and Labels of Medical Devices, CFDA Order No. 6 Publicized as of Oct 01, 2014
- Provision for Clinical Trials of Medical Device, CFDA / National Population and Family Planning Commission of the People’s Republic of China Order No. 25 Publicized as of Mar 23, 2016
- Provision for Recall Management, CFDA Order No. 29 Publicized as of Feb 08, 2017
- The Pharmaceutical Affairs Law (Law No. 145 Established as of August 10, 1960; Law No. 87 Revised as of July 26, 2005) (Japan)
- Standards for Quality Assurance of Drugs, Quasi-drugs, Cosmetics and Medical Devices (MHLW Ministerial Ordinance No. 136 Established as of September 22, 2004) (Japan)
- Standards for Manufacturing Control and Quality Control of Medical Devices and In Vitro Diagnostics (MHLW Ministerial Ordinance No. 169 Revised as of December 17, 2004) (Japan)
- The Drugs and Cosmetics Act & Rules, 1945 (As amended up to the 31st December, 2016) (India)