Onefive, a worldwide leading supplier of femtosecond and picosecond laser modules, announces that it has obtained ISO 9001:2008 and ISO 13485:2003 certifications. The certifications have been accredited by DQS Medizinprodukte.
The ISO 9001:2008 certification shows that the company is committed to provide cutting edge technology and to produce it with the highest levels of quality in all phases of the product’s life. The ISO 13485:2003 standard specifies the requirement for a Quality Management System to ensure the production of devices that strictly fulfill the regulatory requirements of medical device production.
Onefive CEO, Lukas Krainer, states: “We are very thankful to our customers for their continued trust in our products, which led, in the last three years, to an increasing demand of our laser modules for several high-precision applications. Our highest priority is to satisfy our customers with continuous strong commitment to produce safe and accurate devices of the highest industrial standards.
The company has been delivering pulsed laser modules since its foundation in 2005. The reliable, industrial-grade femtosecond and picosecond laser modules have been a solution of choice for many medical integrators in the fields of nano-surgery, microscopy and other medical devices. Onefive products offer high-precision, compactness, ease of use and low post-production maintenance needs which makes them ideal candidates for straightforward, hassle-free integration.