Navigation Links
TraumaCure Receives Prestigious ISO 13485 Certification
Date:6/25/2008

TraumaCure Inc. – makers of the ground-breaking hemostatic agent, WoundStat™ – today announced that the company has received the prestigious international ISO 13485 certification for its quality system for design, development, production and sales of medical devices. The company received FDA clearance to sell WoundStat in August 2007

BETHESDA, Md. (Business Wire EON) June 24, 2008 -- With ISO 13485 certification, TraumaCure meets global quality design and manufacturing requirements. ISO certification is a base-line requirement in many key markets for approval to sell a medical device and therefore supports TraumaCure's plans to market WoundStat to nations around the world.

"As the only hemostatic agent proven to be 100% effective in four different studies, we are seeing worldwide demand for WoundStat," said Devinder Bawa, CEO of TraumaCure. "TraumaCure has put the processes and procedures in place to ensure the global availability of a consistent, safe, and effective product that is ready to save lives, anytime and anywhere it is needed."

ISO (International Organization for Standardization) is the world's largest developer and publisher of International Standards. ISO has more than 16,500 International Standards in its current portfolio, ranging from standards for traditional activities, such as agriculture and construction, through mechanical engineering, manufacturing and distribution, to transport, medical devices, the environment, safety, information and communication technologies, and to standards for good practice and for services.

ISO 13485 is an internationally recognized quality standard for the design, development, production, and sales of medical devices. To be certified, organizations must demonstrate an ability to provide medical devices and related services that consistently meet customer and regulatory requirements.

TraumaCure was certified after rigorous audits and extensive document reviews to ensure that TraumaCure's quality management system (QMS) is run in accordance with the globally recognized standard.

About TraumaCure

TraumaCure, based in Bethesda, Maryland, supplies the most effective, reliable treatments for life-threatening bleeding wounds. TraumaCure's hemostatic products help stabilize a wounded individual prior to receiving advanced medical treatment. The company's products are made in the U.S. and are proven to save lives and improve outcomes following traumatic injury. TraumaCure is committed to providing the most trustworthy and innovative hemostasis treatments for the military, emergency responders, and civilians.


'/>"/>
Source: PRWeb
Copyright©2008 Vocus, Inc.
All rights reserved  

Related biology technology :

1. TraumaCure Receives Prestigious ISO 13485 Certification
2. Reclast(R) Receives US FDA Approval as First and Only Once-Yearly Treatment for Women With Postmenopausal Osteoporosis
3. Ciphergen Biosystems Receives Noncompliance Letter From The Nasdaq Stock Market
4. Indevus Receives Approvable Letter From FDA for VALSTAR(R) for Bladder Cancer Therapy
5. Anesiva Receives FDA Approval for Zingo(TM), a New, Innovative Product to Reduce Pain Associated with Needle Insertion Procedures in Children
6. IsoTis Receives FDA Clearance for Accell Family of Products
7. Actavis Receives Approval of Fentanyl Transdermal System in the U.S.
8. AGA Medical Corporation Receives FDA and CE Mark Approvals for the AMPLATZER Vascular Plug II
9. IDM Pharma Receives Not Approvable Letter for Mifamurtide (L-MTP-PE) for the Treatment of Osteosarcoma
10. XTL Receives Staff Letter From NASDAQ
11. XTL Receives Staff Letter From NASDAQ; XTL may Transfer its ADR Listing to the NASDAQ Capital Market
Post Your Comments:
*Name:
*Comment:
*Email:
Related Image:
 TraumaCure Receives Prestigious ISO 13485 Certification 
(Date:10/11/2017)... ... October 11, 2017 , ... At its national board meeting ... I. Sheikh, the co-founder, CEO and chief research scientist of Minnesota-based Advanced Space ... membership in ARCS Alumni Hall of Fame . ASTER Labs is a ...
(Date:10/11/2017)... ... October 11, 2017 , ... Personal eye wash is a basic first aid supply for any ... So which eye do you rinse first if a dangerous substance enters both eyes? It’s ... Wash with its unique dual eye piece. , “Whether its dirt and debris, or ...
(Date:10/11/2017)... BALTIMORE, Md. (PRWEB) , ... October 11, 2017 ... ... for digital pathology, announced today it will be hosting a Webinar titled, “Pathology ... of  Advanced Pathology Associates , on digital pathology adoption best practices and how ...
(Date:10/11/2017)... LAGUNA HILLS, Calif. , Oct. 11, 2017 ... London (ICR) and University of ... prognostic tool to risk-stratify patients with multiple myeloma (MM), in ... nine . The University of Leeds ... by Myeloma UK, and ICR will perform the testing services ...
Breaking Biology Technology:
(Date:5/16/2017)... , May 16, 2017   Bridge Patient ... organizations, and MD EMR Systems , an ... partner for GE, have established a partnership to ... product and the GE Centricity™ products, including Centricity ... These new integrations will allow ...
(Date:4/17/2017)... NXT-ID, Inc. (NASDAQ: NXTD ) ("NXT-ID" or the ... Annual Report on Form 10-K on Thursday April 13, 2017 with ... ... Relations section of the Company,s website at http://www.nxt-id.com  under "SEC ... . 2016 Year Highlights: Acquisition ...
(Date:4/11/2017)... , April 11, 2017 No two ... researchers at the New York University Tandon School ... Engineering have found that partial similarities between prints ... used in mobile phones and other electronic devices ... The vulnerability lies in the fact that ...
Breaking Biology News(10 mins):