NuvoLase Inc. Receives ISO 13485 Certification
CHICO, Calif.--(BUSINESS WIRE)--Sep 18, 2012--NuvoLase Inc., a privately-held medical device company located in Chico, California and manufacturer of the PinPointe™ FootLaser™, announced today their organization has received their ISO 13485 certification for its Quality Management System. NuvoLase’s scope of registration includes design, development, production, installation and service.
Steven Duddy, President and CEO of NuvoLase Inc., states, “NuvoLase made a corporate decision upon the founding of our organization (approximately one year ago) to obtain certification for our quality system. At that time we recognized the importance of this certification and began the process from the ground up.” The ISO 13485:2003 certification specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services. The primary objective of ISO 13485:2003 is to facilitate harmonized medical device regulatory requirements for quality management systems.
“This certification represents a significant achievement and major milestone for an emerging company such as NuvoLase,” adds Duddy. “Successfully completing this process assists us in moving forward with additional regulatory registrations as well as new product development and design.” About NuvoLase Inc. NuvoLase, Inc. develops and markets innovative devices for healthcare providers worldwide. NuvoLase products are the result of solid research, sound science, and extensive clinical experience, ensuring that they always provide superior clinical performance. The PinPointe FootLaser is available worldwide. For more information, visit our website at www.NuvoLase.com.
NuvoLase, PinPointe, and PinPointe FootLaser are trademarks of NuvoLase, Inc.
NuvoLase Inc. 11 Ilahee Lane Chico, CA 95973 530-809-1970 Patients seeking additional information or a doctor in their area who offers the PinPointe FootLaser procedure can call 1-877-ToeNail (1-877-863-6245) or visit www.PinPointeFootLaser.com/patients/find-a-provider.
Clinicians interested in learning more about the PinPointe FootLaser or interested in purchasing one for their business can contact NuvoLase’s distribution partner, Cynosure Inc., directly at 800-886-2966 or visit their website at www.cynosure.com.CONTACT: NuvoLase Inc.
Steven P. Duddy, 650-918-8596 Fax: 650-548-9009 firstname.lastname@example.org KEYWORD: UNITED STATES NORTH AMERICA CANADA CALIFORNIA INDUSTRY KEYWORD: SURGERY TECHNOLOGY OTHER TECHNOLOGY HEALTH HOSPITALS INFECTIOUS DISEASES MEDICAL DEVICES RADIOLOGY MANUFACTURING ENGINEERING PROFESSIONAL SERVICES OTHER PROFESSIONAL SERVICES FDA SOURCE: NuvoLase Inc. Copyright Business Wire 2012 PUB: 09/18/2012 10:00 AM/DISC: 09/18/2012 10:00 AM http://www.businesswire.com/news/home/20120918005198/