NuvoLase Receives ISO Certification

Chico, Calif.-based NuvoLase Inc., manufacturer of PinPointe and FootLaser (laser treatments for onychomycosis, a fungal infection of the nail most commonly found in feet), has received an ISO 13485 certification for its quality management system. NuvoLase’s scope of registration includes design, development, production, installation and service.

“NuvoLase made a corporate decision upon the founding of our organization (approximately one year ago) to obtain certification for our quality system,” said Steven Duddy, president and CEO of NuvoLase. “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,” added Duddy. “Successfully completing this process assists us in moving forward with additional regulatory registrations as well as new product development and design.”