BrosMed Medical Announces Completes Successful FDA Inspection


Brosmed, Dongguan., April 28, 2018–Brosmed Medical Co. ,Ltd, a leading provider of medical device of cardiovascular and endovascular since 2012, is pleased to announce it successfully completed 4 days Quality System/Current Good Manufacturing Practice regulations for medical devices (21 CFR Part 820) inspection from FDA. This comes as a result of Brosmed medical 5 years ongoing commitment to the highest levels of quality standards.

Stephen Lee, Executive Director, General Manager of Brosmed medical commented, “Successfully completing a four day inspection in which no Form 483 was issued highlights our keen focus on consistently enhancing our quality systems while expanding our medical device technologies and manufacturing experience. This endorsement provides patient safe and effective treatment, and our client with an even higher level of confidence in our partnership.”

“Congratulate BrosMed Medical has been passed this on-site audit by FDA with zero ‘Form 483 Inspectional Observations’, it is an important milestone just like they successfully completed previous Japanese PMDA audit. Once again, Brosmed Medical is constantly proving their excellent performances and high international standard on quality system, technology control and operations management. Cordis Health, as a pioneer and leader in the global cardiovascular and endovascular intervention industry, we are very appreciate that we have been cooperated strategically with Brosmed Medical, an excellent domestic company in China. We both have enough confidence that Cordis and BrosMed will build up strong alliances in wherever domestic and international markets to provide more and more, safe, effective and excellent medical devices to worldwide patients.”–Jessie Lian, GM of Cordis Health China

The FDA investigators performed a thorough and comprehensive inspection, reviewing data from areas such as Quality system requirements, Design control, Production and process, Stability storage and testing, Identification and traceability, Labeling and packaging control, Sterilization, and Microbiology.

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About BrosMed Medical

BrosMed Medical is more than just a company; we are leading the medical device design and manufacturing revolution.

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 Medical product portfolio consist of, Artimes™ PTCA, Apollo™ NC PTCA, Wedge™ Semi-complaint Scoring PTCA, Atropos™ 0.035 PTA, Minerva™ 0.018 PTA, Polux™ 0.014 PTA, Hermes™ NC 0.035 PTA, Achilles™ NC 0.018 PTA, Castor™ NC 0.014 PTA, Conger™ Hydrophilic coated guidewire and Freepath™ Catheter Sheath Introducer. BrosMed Medical is supplying safe, effective and hi-tech medical devices in 30 countries.