ISO 13485:2016
NR Sign Inc. implements globally recognized standards for medical device quality management
Implementation
Building a quality system that holds
ISO 13485:2016 requires a methodical approach. NR Sign Inc. follows each step with precision, from identifying gaps in current processes to training every person involved in the work.
Gap analysis first
We examine what exists and what must change to meet the standard.
Then comes development
Processes are built or refined to ensure compliance at every stage of production.
Documentation and training matter
Every procedure is recorded and every team member understands their role in quality.
StandardRegulatory
What ISO 13485:2016 means for medical devices
This standard governs the complete lifecycle of medical device development and production. NR Sign Inc. adheres to every requirement, ensuring our neurological devices meet the highest international expectations.
Reliable devices
ISO 13485:2016 ensures every neurological device meets rigorous quality standards consistently.
Global compliance
Our certification demonstrates commitment to international medical device regulations and safety requirements.
Enhanced safety
Systematic quality management reduces risk and protects patients using our diagnostic and monitoring solutions.
Our Previous experiences with ITA submission and approval
Previously we have worked on ITA approvals on FTT sensor project with ICORD ( University of British Colombia). Our recent project for free flap tissue sensors which were assigned as class II medical devices. These sensors are supposed to examine oxygenation of the tissue.
Previously we have worked on ITA approvals on FTT sensor project with ICORD ( University of British Colombia)
