At WIVI Vision, we are incredibly proud to have obtained Class IIa medical device certification, making WIVI one of the first vision therapy solutions in Spain to achieve this classification.
This milestone represents an important step forward for WIVI and reflects our commitment to developing healthcare technology in line with the highest standards of safety, performance, and clinical evidence.
Until now, our technology had been certified as a Class I medical device. Moving to Class IIa means meeting a more demanding regulatory framework and successfully completing a conformity assessment process carried out by an independent notified body.
A more demanding regulatory framework for greater assurance
Class IIa certification confirms compliance with the requirements established by the European Medical Device Regulation and involved an assessment of different areas of WIVI, including technical documentation, risk management, and the processes implemented throughout the solution’s lifecycle.
For eye care professionals and patients, this process provides additional assurance regarding the safety and performance of the technology. It also strengthens confidence in a solution designed with mechanisms to identify, control, and minimize potential risks associated with its use.
Behind every assessment, every therapy session, every measurement, and every program developed with WIVI is a rigorous process subject to external oversight. It is part of our commitment to ensuring that innovation in healthcare is always accompanied by the highest level of standards.
A double endorsement for WIVI: Class IIa and ISO 13485
The achievement of Class IIa medical device certification also coincides with the renewal of WIVI Vision’s ISO 13485 certification for its quality management system, which was also audited by TÜV SÜD.
Both milestones reinforce our commitment to quality, traceability, and continuous improvement in the development and management of medical devices.
For WIVI, this is about more than meeting a regulatory requirement. It confirms the path we have been building for years: developing healthcare technology with the rigor needed to earn the trust of professionals and patients.
We will continue moving forward with a clear goal: raising the standard of visual health and helping improve people’s quality of life through better vision.
Want to learn more about WIVI technology and how it can help assess and train visual efficiency? Get in touch with our team and discover WIVI.