Wound Care Technologies, Inc. is pleased to have received ISO 13485 certification as a medical device manufacturer and distributor. This vital quality management system certification specifies that Wound Care Technologies, the manufacturer of DermaClose® External Tissue Expander, has met the requirements necessary to provide medical devices and related services that consistently meet customer and regulatory requirements.
“We are proud of the hard work that went into attaining this vital certification. It is further proof of our unwavering commitment to our surgeons and their patients throughout the world,” said Paul Anderson, CEO of Wound Care Technologies, the manufacturer of DermaClose. “This achievement is also a key step in our goal toward marketing the DermaClose worldwide,” he said.
According to the International Organization for Standardization based out of Geneva, Switzerland, “ISO 13485 helps an organization design a quality management system that establishes and maintains the effectiveness of its processes. It reflects a strong commitment to continual improvement and gives customers confidence in the company’s ability to bring safe and effective products to market.”
The DermaClose® is a controlled force, continuous external tissue expander that facilitates rapid tissue movement to reduce or re-approximate wounds. The DermaClose expands skin around a wound until it has stretched enough to enable the wound edges to be sutured closed. It provides surgeons an alternative to skin grafts while improving clinical outcomes and patient satisfaction. To date, DermaClose has been used in over 17,000 cases in the United States and is backed by 46 published case reports and 20 clinical publications.
