BrosMed Medical Earns MDSAP Certification
Release time:
2023-06-21
Dongguan-June 21, 2023-Today BrosMed announced that it has earned the Medical Device Single Audit Program (MDSAP) certification, indicating that the single regulatory audit to BrosMed satisfies the requirements of multiple regulatory jurisdictions participating in the program.
Dongguan-June 21, 2023-Today BrosMed announced that it has earned the Medical Device Single Audit Program (MDSAP) certification, indicating that the single regulatory audit to BrosMed satisfies the requirements of multiple regulatory jurisdictions participating in the program.
The MDSAP is a unique program that brings the internationally leading regulatory agencies together to perform a single regulatory audit of a medical device manufacturer´s quality management system to satisfy the requirements of multiple regulatory jurisdictions, including the Therapeutic Goods Administration of Australia, Brazil’s Agência Nacional de Vigilância Sanitária, Health Canada, Japan’s Ministry of Health, Labour and Welfare and Japanese Pharmaceuticals and Medical Devices Agency, and the U.S. Food and Drug Administration. This certification confirms BrosMed’s compliance with the high standards and regulatory requirements of most leading countries in the world.
“This certification is a key achievement for us on the road to global commercialization. It is a critical step forward in offering our intravascular interventional solutions to additional markets and reinforces our commitment to quality and safety,” said Winnie Huang, BrosMed Quality Director.
At present, BrosMed has more than 20 product series sold to over 80 countries and regions. BrosMed will continue to reinforce our commitment to high-standard quality and safety and provide more innovative products for patients around the globe.
Contact Us to Become BrosMed Partner!
Please fill out this form and we will get in touch within 24 hours.
* Note: Please be sure to fill in the information accurately and keep the communication unblocked. We will get in touch with you as soon as possible.
More news
Meet BrosMed at ESC Congress 2024
BrosMed Medical is delighted to participate in the ESC Congress 2024 from August 30th to September 2nd in London, UK.
2024-08-15
BrosMed Medical Announces Scott J. Addonizio as Chief Operating Officer
2024 August 1st – BrosMed Medical is pleased to announce the appointment of Scott J. Addonizio as its Chief Operating Officer (COO), effective immediately. Mr. Scott J. Addonizio brings a wealth of experience and expertise to BrosMed, with a distinguished career spanning almost 30 years in the medical device industry. Prior to joining BrosMed, Mr. Addonizio served as SVP at Cordis and COO at MedAlliance Swiss Medical Technology.
2024-08-01
CTO&CHIP PCI – Insights from the clinical practice (Ⅱ)
July 30, 2024 @16:00-17:30 (Beijing Time) Join BrosMed Medical on Tuesday, July 30 for an enlightening discussion that unites cardiologists from Malaysia, China, India, Tunisia and Portugal, where clinical expertise harmoniously fuses with CTO&CHIP innovation. At this exclusive webinar, we’re orchestrating a confluence of valuable insights, drawing from the collective wisdom of seasoned interventional cardiologists.
2024-07-26
BrosMed Announced CE MDR Approval of New Generation PTA SC Balloon Dilatation Catheters
May 27, 2024- BrosMed announced that it receives European Medical Device Regulation (MDR) certification for the New Generation PTA SC Balloon Dilatation Catheters (Brand Name: Polux™ Pro 014, Minerva™ Pro 018 and Atropos™ Pro 035).
2024-05-27
Meet BrosMed at Leipzig Interventional Course (LINC 2024)
We’re excited to announce that BrosMed team will attend LINC 2024 from May 28th to 31th in Leipzig, Germany. Leipzig Interventional Course is an exciting event that bringing the global vascular community together. As a company committed to improving clinic outcomes through innovative medical devices, we look forward to connecting with industry experts, physicians, and partners at this premier conference.
2024-05-14
Webinar Invitation | Creating A Successful Endovascular Practice. Apr. 29
Date: April 29, 2024 Time: 17:00-19:10 (Korean Standard Time) 16:00-18:10 (Beijing Time) 16:00-18:10 (Malaysia Time) 11:00-13:10 (Moscow Standard Time) 11:00-13:10 (Egypt Standard Time)
2024-04-24