Quality assurance
Certificates
The ISO 13485 is an international standard for quality management systems specifically designed for the medical device industry.
MDR 2017/745 is a regulation that governs the manufacturing, marketing, and distribution of medical devices within the European Union (EU)
As we are certified in both, we work to reduce risks from the design stage all the way to when in use, ensuring devices are safe and work well.
Quality
Our products are specially designed and handcrafted by experienced and highly professional skilled workers. The products go through several quality control processes so we can assure all necessary quality parameters before leaving our premises.
Our processes and systems align with International Standards and Requirements, making our products compliant and accredited by notified bodies and authorities.
