ISO 13485:2016 COMPLIANT
Our company complies with the EU MDR 2020 requirements for medical devices
EU MDR 2020
ISO-13485 is a quality management system standard specific to companies in the medical sector, which includes aspects of the ISO-9001 standard and specific requirements for the medical device industry.
The ISO-13485 certification is a tool aimed at companies that supply medical devices, both standard and custom-made, without limitations regarding the type and size of the organization. The main objective of ISO-13485 is to reduce risk, improving patient safety.
Certification and compliance with ISO-13485 will be a competitive differentiation factor for companies. Being certified for the MD standard will increase the likelihood of reaching potential customers.
We are well aware of the influence of software on the safety and performance of medical devices.
Precisely for this reason, we guarantee absolute traceability, timely interventions in cases of suspected or claimed non-compliance and the necessary regulatory documentation for all products distributed to allow our customers to pursue the desired certifications.