AG has received certification according to European Norm (EN) ISO 13485:2003
+ AC:2007. As part of its audit, Medcert GmbH, the medical certification and
testing company, examined the quality management systems of MagForce in the
areas of development, manufacturing, final inspection and distribution for the
products used for its therapy systems for hyperthermia and thermoablation, including
the related treatment planning software, and determined that all requirements
of the ISO standard were properly fulfilled. Once the CE conformity assessment
procedures have been completed for all components, this certification will mark
a final key step toward the successful commercialization of the company’s
"We are extremely pleased to have received this latest certification,
which now also confirms that the development areas for our NanoTherm® and
NanoPlan® products, audited for the first time, likewise fulfill the requirements
for a rigorous quality management system. This represents another key step on
the road toward the European market launch of our novel cancer treatment approach,"
said Dr. Uwe Maschek, CEO of MagForce Nanotechnologies AG.
MagForce Nanotechnologies AG is the world’s leading company in the area
of nanotechnology-based cancer treatment. Its patented Nano-Cancer® therapy
allows the targeted destruction of tumors using superparamagnetic nanoparticles
to generate heat. The nanotechnology from MagForce represents a revolutionary
approach to the future successful treatment of solid tumors.