ISO 13485:2016 – Medical devices Quality management systems

ISO 13485:2016 is an international standard that specifies requirements for establishing and maintaining a quality management system (QMS) for medical devices. It is specifically designed for organizations involved in the design, development, production, installation, and servicing of medical devices. The standard focuses on ensuring that these organizations consistently meet customer and regulatory requirements while demonstrating their ability to provide safe and effective medical devices.
By implementing ISO 13485:2016, medical device organizations can establish a robust QMS that focuses on product safety, customer satisfaction, and regulatory compliance. Compliance with the standard demonstrates a commitment to quality and provides assurance to customers, regulators, and other stakeholders that the organization is dedicated to producing safe and effective medical devices.

Smart Star Consulting Methodology

SMART STAR specialist consultants offer comprehensive Consultancy services based on the ISO 13485:2016 standards. Our team of experts assists organizations in implementing and achieving compliance with ISO 13485:2016, enabling them to establish robust quality management system (QMS) for medical devices. Through our tailored consultancy approach, we help organizations optimize their processes, enhance stakeholder satisfaction, and drive continual improvement

• Development of Project Plan
• Formation of Project Team – Consultant & Client
• Gap Analysis
• Management System Development
• Awareness & Internal Auditor Training
• Management System Implementation Assistance
• Internal Audit and Management Review Assistance
• Certification Audit Assistance
• Continual Improvement & System Maintenance Assistance