Presbyopia Optana
Quality and ISO13485:2003
Quality is OPTANA's obligation and requirement
OPTANA's quality statement
In order to be able to fulfil customer's requests optimally OPTANA aspires a high product reliability concomitant related with timeliness, high performance, promptness and exemplary customer service.
The basis for quality is the professional expertise of our employees and our critical attitude of taking over only those tasks that match our capabilities, experiences and resources.
Above all the medical technology and the use of devices at humans within the range of the quality assurance require a high measure of perfection, foresight and the process-spanning awareness to recognize risks and endangerments and, respectively to introduce effective measures.
Due to the responsibility respectful toward the patient this awareness concerning quality has highest value within OPTANA.
Compliance with ISO 13485:2003
Our validated quality assurance system according to ISO 13485:2003 regulates all demanded medical quality assurance measures and is a very important basis for world-wide product approval and mandatory in Europe. OPTANA continuously improves the quality system to ensure a vivid and controlled process environment in the company. These measures are validated by our notified body during our annual quality audits.
