In a world of rapidly changing regulatory requirements, achieving new certifications, such as ISO 13485:2016, doesn’t have to be a burdensome eort. Implementing an electronic quality management system (eQMS) that will scale with your company and simplify navigating the continuously changing regulatory environment is a true advantage for companies that want to lead with quality, meet regulatory requirements, and build out a foundation for growth. Companies such as Lucerno Dynamics have taken this progressive approach by digitizing and automating their quality processes in order to smooth their path to ISO 13485:2016 certification. Lucerno Dynamics currently has a line of Class I devices that dynamically detect and record the presence of radiolabeled biomarkers that may aect PE

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