Visibly Secures CE Mark Approval for its Digital Acuity Test
Visibly, a key player in vision care innovation, has recently gained attention for receiving CE Mark Approval for its pioneering Visibly Digital Acuity Product (VDAP) in the European Union. This important development confirms Visibly's dedication to providing effective and safe vision care products that comply with rigorous EU Medical Device Regulations.
Commitment to Quality and Innovation
Alongside obtaining CE Mark Approval, Visibly has also secured the EN ISO 13485 certification. This certification signifies the consistent quality and reliability of the medical devices manufactured by Visibly. It underscores the company's dedication to designing, developing, and producing vision care solutions that meet the highest safety and effectiveness standards.
Impact of CE Mark Approval
The CE Mark Approval marks a significant achievement for Visibly, opening doors for the company's growth in the global market. Michael B. Vader, Vice President of Regulatory Affairs and Quality Assurance at Visibly, expressed his excitement about this milestone, noting that it allows Visibly to offer affordable vision care solutions to consumers worldwide.
Accessible Vision Care
With the CE Mark Approval in place, millions of individuals in the European Union will soon be able to access Visibly's innovative online visual acuity test right from the comfort of their homes. By utilizing a simple combination of a touchscreen mobile device and an internet-connected computer, users can take the self-administered visual acuity test conveniently. This initiative aims to enhance access to vital vision care services, making them more available to those who need them.
Future Collaborations and Innovations
Visibly is looking ahead and seeking partnerships with leading optical organizations throughout the EU. Through these collaborations, the company aims to equip eye care professionals with advanced digital tools to improve patient engagement and expand their service reach. The objective is to create a more efficient eye care system that simplifies and enhances access for everyone.
About Visibly
Founded in 2012 and headquartered in Chicago, Visibly has been a leader in developing digital vision care solutions. Its mission is to improve patient choices while empowering providers. The launch of online vision testing is just the beginning for Visibly, as the company envisions a future where technology enables smoother interactions between patients and healthcare providers in the vision care field.
Frequently Asked Questions
What is CE Mark Approval?
CE Mark Approval indicates that a product has met essential safety, health, and environmental protection standards for products sold in the European Economic Area.
What is the purpose of the Visibly Digital Acuity Product?
The VDAP allows users to carry out self-administered visual acuity tests from home, using straightforward technology.
How does Visibly ensure quality in its products?
Visibly upholds high quality standards through certifications like the EN ISO 13485, which ensures quality management in the design and production of medical devices.
Where is Visibly based?
Visibly's headquarters is located in Chicago, Illinois, and the company focuses on innovative vision care solutions.
What future plans does Visibly have in the EU market?
Visibly intends to collaborate with optical organizations in the EU to extend the reach of its digital vision care solutions among eye care professionals.
