Visibly Achieves International Milestone with CE Mark Approval in the European Union (EU)
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CHICAGO, Sept. 18, 2024 ~ Visibly, a company known for its innovative vision care solutions and the creator of the world's first FDA-cleared online visual acuity test, has recently achieved two major milestones. The company is pleased to announce that its Visibly Digital Acuity Product (VDAP) has received CE Mark Approval in the European Union (EU), demonstrating compliance with the EU Medical Device Regulation (MDR). This approval is a significant step towards expanding Visibly's platform into the global market and providing affordable access to vision care services.

In addition to this, Visibly has also received the EN ISO 13485 certification, further solidifying its commitment to developing high-quality and effective products for vision care. This international standard ensures that medical devices are designed, developed, produced, and delivered in a consistent and efficient manner, making them safe for their intended purpose.

Michael B. Vader, Vice President of Regulatory Affairs and Quality Assurance at Visibly, Inc., expressed his excitement about these achievements. He stated that these milestones are a testament to the dedication of the Visibly team in expanding safe and effective vision care services to consumers. The CE Mark Approval of VDAP in the EU marks an important milestone for Visibly as it takes its first step towards entering the global marketplace.

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With these certifications in place, consumers in the EU can soon access Visibly's on-demand visual acuity test from their homes using a combination of a touchscreen mobile device and computer connected to the internet. This will provide them with convenient and affordable access to vision care solutions.

Brent Rasmussen, CEO of Visibly, also shared his thoughts on these achievements. He stated that these certifications are proof of the consistency and efficacy of Visibly's online visual acuity test design and delivery processes. He further added that they are excited about the opportunities ahead and remain committed to increasing access to vision care solutions.

Visibly's online vision platform has been successful in expanding affordable access to vision care for millions of consumers. With the CE Mark Approval of VDAP and EN ISO 13485 certification of the Quality Management System, Visibly is now looking forward to partnering with leading EU optical organizations to equip eye care professionals with digital solutions that will help them expand their patient reach.

To learn more about Visibly's visual acuity test and portfolio of products, interested individuals can visit the company's website. With these recent achievements, Visibly is well on its way to achieving its goal of providing affordable access to vision care services globally.

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