Radiance obtains EC and FDA certification as a healthcare product

GMV has obtained EC and FDA certification for its Intraplan radiance healthcare product. These certifications have been gained on the strength of a quality management system (QMS) for the development of intraoperative radiotherapy planning tools under the ISO 13485 and ISO 9001 standards. Its QMS has also been certified under the same standard. GMV thus fulfils all the regulatory requirements laid down in Europe and the USA.

radiance boosts safety and security in intraoperative radiation therapy (IORT). If offers a planning system that allows physicians, using a complex simulation system, to modify various surgery and radiotherapy parameters before going ahead with the treatment, gauging beforehand the impact of the therapy on the patient, adjusting radiation levels to suit and fine-tuning the whole operation.

The system has been taken up by some of the world’s benchmark oncology centers, like Hospital General Universitario Gregorio Marañón and, more recently, King Fahd Medical City in Riad in Saudi Arabia. This certification now gives a new boost to the product’s international expansion and innovation.