Life Recovery Systems Achieves Certification To The International Medical Device QMS Standard - ISO 13485:2003
Published: Oct 02, 2006
KINNELON, N.J., Sept. 29 /PRNewswire/ -- Life Recovery Systems HD, LLC (http://www.life-recovery.com) announced today that the company has recently received certification to the international medical device quality management standard, ISO 13485:2003. This international standard specifies requirements for a quality management system covering the design, development, production, installation and servicing of medical devices and the provision of related services.
Commenting on the certification, Robert J. Freedman MD, President of Life Recovery Systems, said, "We are pleased to announce our achievement of certification to ISO 13485. This accomplishment recognizes the effectiveness of our Quality Management System and is a milestone in bringing our innovative products to market. Our focus is on ensuring the highest quality products and services for our customers through compliance with the requirements of ISO 13485:2003 and the US FDA Quality System Regulation (21 CFR Part 820)."
About Life Recovery Systems:
Life Recovery Systems (LRS) is a privately help firm focused on ground breaking, innovative medical devices for the emergency medical care market. LRS designs, manufactures, and markets patented and proprietary products for life saving applications. The company has targeted this market to provide therapeutic solutions for patients that have experienced cardiac arrest, stroke, heart attack or trauma. The company is incorporated in the State of Louisiana, with operations and research offices in Kinnelon, New Jersey.
Life Recovery Systems has developed an innovative system for rapidly cooling a patient's core temperature: the ThermoSuit(TM) System (TSS). The TSS consists of a disposable body suit and a means to pump coolant within the suit over the skin of the patient. It is the first device for patient temperature management that conveniently provides a thin layer of rapidly flowing liquid coolant in direct contact with the skin. This approach gives the TSS outstanding capabilities to rapidly and non-invasively change patient temperature. The TSS approach is covered under issued and pending U.S. patents exclusively licensed to Life Recovery Systems. This device has been designed for ease of use by the clinicians who treat Cardiac Arrest patients and has the potential to quickly cool these patients and potentially increase their survival. Recent guidelines issued by the American Heart Association suggest early and rapid cooling of patients who have suffered an Arrest may improve their chances of survival. Life Recovery Systems' ThermoSuit(TM) System is a breakthrough device in the field of Therapeutic Hypothermia. Patient cooling performance is unequalled in the marketplace.
More information about Life Recovery Systems can be found at http://www.life-recovery.com. Contacts: For More Information: Robert J. Freedman, MD Freedman Memorial Cardiology 3311 Prescott Road, Suite 211 Alexandria, LA 71303 Tel. (318) 767-0960 firstname.lastname@example.org Life Recovery Systems HD, LLC John DiLiddo; VP, Marketing & Bus. Development 170 Kinnelon Road, Suite 9 Kinnelon, NJ 07405 Tel. (973) 283-2800, Fax. (973) 283-2910 email@example.comLife Recovery Systems HD, LLC
CONTACT: Robert J. Freedman, MD, +1-318-767-0960, firstname.lastname@example.org,or John DiLiddo, VP, Marketing & Bus. Development, +1-973-283-2800, or Fax:+1-973-283-2910, email@example.com, both of Life Recovery SystemsHD, LLC
Web site: http://www.life-recovery.com/