Quality that builds trust

How we ensure MDR-compliant quality, safety, and clinical evidence — so TES therapy can be reliably integrated into everyday practice.

OkuStim® 2 – Person holt das Device aus der Verpackung

From Development and Clinical Evaluation to Everyday Use

At Okuvision, quality is not a label, but a process—from development and clinical evaluation through to everyday care. “We test our products in accordance with all applicable European standards … and conduct clinical studies to ensure that our products deliver the promised performance.”

On CE marking, Fabian Kaiser (QMB) explains: “CE marking is like an ID card. Without the CE mark, a product cannot be placed on the market in Europe.” And on quality assurance in practice: “We are audited every year … and test all products before they leave our facility.” “Only when all tests have been successfully completed does a safe and effective product leave our facility.”

MDR Compliance & CE Marking

OkuStim® is an active medical device with CE marking in accordance with MDR (EU) 2017/745; notified body: TÜV Rheinland (0197).
The intended use, safe application, and maintenance are described in the instructions for use; the stimulation parameters are programmed by a physician.
Annual audits by the notified body and internal audits ensure CE conformity.

"This is the only way we can ensure that our products meet all requirements and are safe and effective."

Fabian Kaiser, Quality Management

Safety & Clinical Evidence

In controlled trials and observational data on TES with OkuStim®, no therapy- or device-related serious adverse events (SAEs) have been reported; the most common side effect is temporary eye dryness, which can be effectively managed with artificial tears.

Randomized and prospective clinical trials (e.g., EST series, TESOLA) demonstrate safety; exploratory analyses show a dose-dependent slowing of visual field loss.

In summary, the evidence shows that regular, low-intensity electrical stimulation can slow the loss of visual field in RP and thus preserve vision-related quality of life for longer.

What we mean by “safety”:

No device- or therapy- related serious adverse events (SAEs) in multicenter safety trials
Dose-response evidence for slowing of visual field loss
Home-based therapy with physician-prescribed parameters (30 min/week)

Usability & Accessibility in Everyday Use

The system is designed for independent use – with clear tactile feedback, LED indicators, and acoustic system notifications that provide support even in advanced stages. The instructions for use cover controls, signals, and the safe conduct of sessions.

Electromagnetic Compatibility (EMC)

The device meets EMC requirements in accordance with CISPR 11, Group 1, Class B – suitable for home environments, medical practices, and clinics. Usage instructions minimize interference and ensure reproducible therapy sessions.

Post-Market Surveillance and Transparency

We systematically monitor safety, performance, and user feedback (“PMS”) and continuously feed findings back into product maintenance and user information (e.g., recommendation of artificial tears for dryness, guidance on electrode handling and comfort).
In parallel, long-term clinical data are collected in multicenter programs; the German G-BA trial study (TES-RP) investigates patient-relevant endpoints over several years.