Orlando, FL, USA
618 E. South Street, Suite 500
Write to us
info@qsiglobalventures.com
618 E. South Street, Suite 500
info@qsiglobalventures.com
QSI offers a variety of support services to help your organization effectively and efficiently achieve its mission-critical objectives.
Given our 30 years of working with Fortune 100 corporations and government institutions, our professional and experienced value-added services can help your organization increase operational effectiveness through the application of best practices based on internationally recognized standards.
618 E. South Street, Suite 500, Orlando, FL, USA
This is a basic course that is ideal for anyone interested in learning the purpose of 13485:2016, as well as how to apply its principles and requirements to establish, implement, and operate a Medical Device Quality Management System based on 13485:2016.
This course can be delivered online or on-site, and is typically a precursor module to the Auditor, Lead Auditor, Consultant and/or Coach courses for 13485:2016.
Este curso se puede impartir en línea o en el sitio, y suele ser un módulo precursor de los cursos Auditor, Auditor Líder, Consultor y / o Coach para 13485:2016.
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ISO 13485:2016 focuses on ensuring compliance with applicable regulatory and standards requirements, as well as improving the quality and safety of medical devices. Its implementation has a significant impact by improving product reliability, strengthening risk management, increasing operational efficiency and fostering customer and stakeholder confidence.
“Quality is not an act, it is a habit”
Aristotle
Goals
Methodology
Our methodology is practical and based on the analysis of real cases that allow the participant to obtain an appropriate balance of theory and practice, facilitating learning and performance.
This course includes support materials and interactive workshops that help students achieve the learning objectives.
This course is 8 hours long and can be taken online or on-site.
Requirements
618 E. South Street, Suite 500
info@qsiglobalventures.com