CERTIFIED PROCESSES AND DETAILED CONTROL
We focus on the quality and safety of our products, conducting rigorous analyses to eliminate any risk of malfunction, contamination, or breakage, following very high quality standards. We use advanced design, production, and control systems to optimize the process and minimize the risk of errors or defects. Our devices comply with the MDR Regulation 2017/745 and bear the CE mark. Accurate monitoring of the production process through advanced IT systems ensures complete traceability of the devices. Our commitment to quality is the best guarantee of reliability. For more details on our quality standards, see below:
ISO 9001 quality confirms Strena Medical's orientation towards the formalization of procedures to ensure high quality standards and the continuous improvement of their efforts, also collecting customer feedback and suggestions.
ISO 13485 specifies requirements for a comprehensive quality management system for the design and manufacture of medical devices and related services that meet customer requirements and applicable regulatory requirements.
The CE marking is the manufacturer's declaration of a medical device that certifies that the product meets the general safety and performance requirements necessary to be placed on the European market.
CERTIFIED AND REGISTERED IN 24 COUNTRIES WORLDWIDE
RECOGNITIONS
