Navigation Links
GlySure Earns ISO 13485 Certification
Date:3/5/2013

OXFORD, England, March 5, 2013 /PRNewswire/ --

GlySure Limited, developer of in-hospital continuous blood glucose monitoring systems, today announced that it has achieved ISO 13485 certification, the global standard for the requirements of a quality management system for the design, manufacture and distribution of medical devices. By establishing a quality management system that meets international regulatory and customer requirements, GlySure has set the foundation for its European clinical trials.

"This is an exciting time for our company as we conclude our prototype trials and turn our sights toward securing a CE mark," said GlySure CEO Chris Jones . "ISO 13485 certification is a key step in this transition as it validates our quality management system and ability to consistently deliver safe and effective technologies to the global marketplace."

GlySure's continuous blood glucose monitoring (CBGM) technology meets the clinically documented need for Tight Glycemic Control (TGC) in the Intensive Care Unit (ICU), which has been shown to improve outcomes, reduce mortality and cut the cost of care.

ISO certification is the latest in a series of recent key achievements for GlySure as it prepares for regulatory trials. Over the past year the company has expanded its manufacturing, quality and development teams, opened a new manufacturing facility in Oxfordshire, England and is nearing completion of pre-clinical trials in over 120 ICU patients. GlySure anticipates that it will begin CE mark trials of its CGM system in the second quarter of 2013.

For more information on GlySure, TGC and CBGM technology, visit http://www.glysure.com.

About GlySure:

GlySure has developed a continuous intravascular glucose monitoring system using a proprietary optical fluorescence sensor to meet the $2B+ worldwide demand for implementation of Tight Glycemic Control (TGC) in the hospital Intensive Care Unit (ICU). The company has demonstrated through ICU testing highly accurate sensors, which can provide continuous glucose readings throughout the length of a patient's stay in the ICU. GlySure was founded in 2006, it is based in Abingdon, Oxfordshire, England and it has 23 employees. The company's products are not approved for use in the U.S. or Europe. http://www.glysure.com

Company Contact: Chris Jones , CEO, GlySure. Tel: +44(0)1235-462-870. cjones@glysure.com
Media Contact: Bruce Dodworth , Sea Glass PR. Tel: +44(0)1780-758555. bruce@seaglasspr.com


'/>"/>
SOURCE GlySure
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Arkansas Prostate Cancer Center Earns High Honor of ACR-ASTRO Accreditation
2. ZirMeds SaaS Solution Earns EHNAC HNAP Certification
3. Cardiac Science Earns Top Marks for Cardiac Stress Test, Telemetry Monitor Systems
4. Agendia Earns ISO Certification for Facilities in Amsterdam and Irvine
5. MedicareBlue Rx Drug Plan Earns Federal Governments Top Rating
6. Isis Initates Phase 2/3 Study Of ISIS-TTR Rx And Earns $7.5 Million Milestone Payment From GlaxoSmithKline
7. Plainfield Precision Achieves ISO 13485:2003 Quality Management Certification for Medical Device Manufacturing
8. Solos Endoscopy and TUV SUD America Schedule Stage 1 ISO 13485 Audit for February 26, 2013
9. MDI Announces ISO 13485 Certification
10. GPMG Product Helps Medical Device Specification Developers be FDA and ISO 13485 Compliant
11. PDR and the iHealth Alliance Announce New Drug Safety Certification for EHRs
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/23/2016)... , June 23, 2016 Any dentist who ... challenges of the current process. Many of them do not ... the technical difficulties and high laboratory costs involved. And those ... offer it at such a high cost that the majority ... Dr. Parsa Zadeh , founder of Dental ...
(Date:6/23/2016)... LOS ANGELES , June 23, 2016 /PRNewswire/ ... (NASDAQ: CAPR ), a biotechnology company ... first-in-class therapeutics, today announced that patient enrollment in ... progrEssion in Duchenne) has exceeded 50% of its ... its enrollment in the third quarter of 2016, ...
(Date:6/23/2016)... 23, 2016  Astellas today announced the establishment of Astellas Farma Colombia (AFC), a new affiliate with operations headquartered ... Latin America . ... ... ... ...
Breaking Medicine Technology:
(Date:6/25/2016)... ... June 25, 2016 , ... Conventional wisdom preaches the benefits of moderation, whether ... latter, setting the bar too high can result in disappointment, perhaps even self-loathing. However, ... their goal. , Research from PsychTests.com reveals that behind the tendency ...
(Date:6/24/2016)... ... ... June 19, 2016 is World Sickle Cell Observance Day. In an effort ... holistic treatments, Serenity Recovery Center of Marne, Michigan, has issued a pain ... Disease (SCD) is a disorder of the red blood cells, which can cause episodes ...
(Date:6/24/2016)... ... June 24, 2016 , ... Global law firm Greenberg Traurig, P.A. ... The attorneys chosen by their peers for this recognition are considered among the top ... Shareholders received special honors as members of this year’s Legal Elite Hall of Fame: ...
(Date:6/24/2016)... NY (PRWEB) , ... June 24, 2016 , ... Topical BioMedics, Inc, makers of Topricin ... companies that call for a minimum wage raise to $12 an hour by 2020 and ... This will restore the lost value of the minimum wage, assure the wage floor does ...
(Date:6/24/2016)... ... June 24, 2016 , ... ... to recognize Dr. Barry M. Weintraub as a prominent plastic surgeon and the ... in the world, and the most handsome men, look naturally attractive. Plastic surgery ...
Breaking Medicine News(10 mins):