IRVINE, Calif.– Today Viseon Inc. announced that it has received Quality Management and CE Mark Certification for their MaxView® System device under the new MDR. The EU MDR is the set of regulations that governs the worldwide production and European distribution of medical devices. Compliance with this regulation is mandatory for medical device companies to legally market and sell their products in the EEA (European Economic Area). As part of the new regulations, all manufacturers of medical devices for sale within the EU must adhere to more strict guidelines to ensure their products are safe to use.
Commenting on the MDR certification milestone, Viseon President and Chief Operating Officer Pete Davis stated, “The regulatory hurdle for commercializing medical devices in the EU has changed dramatically in recent years, now equivalent to, if not a higher bar than, US FDA regulations. Since its founding, Viseon has been managed day-to-day to grow a company with a sustaining infrastructure and differentiating proprietary technology. Our Notified Body auditors have acknowledged that very few MedTech companies have achieved MDR certification. Thanks to the hard work of our team, Viseon has distinguished itself in the MedTech industry to be among the first to achieve this important milestone.”
Viseon will be launching the next generation 4K MaxView System later this year that will enable the user to seamlessly record and store clinical procedures with 4K HD resolution for enhanced teaching & learning, building of a digital database supporting the value of MaxView technology, as well as expanding strategic initiatives. Viseon also plans to expand into the evolving field of minimally invasive endoscopic spine surgery, offering additional differentiating benefits from their proprietary device design for the surgeon and patient.
