Quality & Regulatory
We are able to comply with all regulations and to deliver on all continents.
Every day, in all our activities, we are committed to moving towards excellence and performance.
SYMATESE has always considered the quality of its products and the safety of patients as its main target, and has implemented an effective quality system and meeting the most stringent international regulatory requirements (ISO 13485 and QSR – 21 CFR part 820).
Our daily goal is to guarantee that patients receive a safe, high quality product meeting regulatory and legal requirements.
The integration of tools such as the PDCA system (Plan-Do-Check-Act) and the importance of training in the SYMATESE quality management system contribute to our commitment and guarantee the high quality and safety of our products.
Good Manufacturing Practices (GMP, Quality System Regulation CFR820) and the current European directive MDD93/42 and future Medical Device Regulation (MDR) as per May 2021 constitute the regulatory basis of the SYMATESE quality management system.
All our medical devices and products are CE marked.