What does Okuvision do for patients and medicine?

Okuvision GmbH develops, produces, and distributes the therapy system OkuStim for electrostimulation therapy in ophthalmology.

Milestones

Okuvision GmbH was founded in 2007. After clinical studies, the OkuStim therapy system was introduced in 2014.
With the help of an investor Okuvision today ensures the supply of the OkuStim therapy system and consumables as well as the continuous development of the therapy.

 

 

2007

Foundation of Okuvision GmbH as a subsidiary of Retina Implant AG.

 

2011

Completion of the pilot study EST I.

 

2011

Okuvision receives the CE mark class IIa for the product OkuStim.

 

2014

Completion of the follow-up study EST II.

 

2015

Completion of the TESOLA study (post marketing observational study).

 

2016

Okuvision receives the re-certification of the CE-marking class IIa for the OkuStim product.

 

2017

Merger of Okuvision GmbH and Retina Implant AG.

 

2019

Okuvision GmbH resumes independent operation after the dissolution of Retina Implant AG to continue the therapy and to ensure the supply of electrodes.

 

2020

Following Okuvision's successful re-certification as a medical device manufacturer, the OkuStim system is CE marked as a Class IIa medical device.

Quality Policy

Our highest quality goals are a convincing service, a product quality meeting the requirements and the safe application of our products.

As a legal manufacturer of medical devices, we are obliged to certify our quality management system according to ISO 13485. This certification is congruent with the certification according to ISO 9001 and goes beyond it, especially in the case of special regulatory requirements for medical technology.

Downloads:
Annex II, excluding section 4 of the directive 93/42/EEC
ISO 13485:2016 certificate

 

Compliance

A fundamental principle of Okuvision GmbH in its cooperation with doctors, medical institutions and all business partners is both ethically impeccable conduct and strict compliance with applicable law.

Our compliance guidelines regulate this cooperation in binding principles.