Pyng Medical has obtained recertification to ISO 13485:2003 standard and has certified to the new ISO 9001:2008 standard.
Pyng Medical said that the company has also retained their CE Mark for CRIC Cricothyrotomy System, FAST1 Intraosseous Infusion System and FASTx Sternal Intraosseous Device without any major or minor nonconformities.
FAST1 is the medical device able to provide rapid sternal access for administering drugs and fluids to the heart in seconds.
Pyng Medical claimed that the certification process, which occurs every three years, confirms company’s ability to meet or exceed the stringent Quality Management System protocols and the regulations required of the medical device industry throughout the world.
Pyng Medical continues to commercialise trauma and resuscitation products for front-line critical care personnel. Pyng’s expanded product portfolio includes a variety of lifesaving tools including FAST1 Intraosseous Infusion System.
With growing markets in North America, Europe and Asia, Pyng offers user-preferred medical devices for use by hospital staff, emergency medical services and military forces worldwide.