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ISO 13485:2016 is an international standard that descibes the essential for a Quality Management System (QMS) for medical devices. It is designed to assist organizations demonstrate their ability to provide medical devices that consistently meet customer and regulatory essential.

Key Philosophy of ISO 13485:2016

  • Quality Management System: Establish a QMS that meets the essential of ISO 13485:2016.
  • Risk Management: Find out and control risks connected with medical devices.
  • Regulatory Compliance: Demonstrate compliance with regulatory essential for medical devices.
  • Customer Focus: Focus on meeting customer essentual and expectations.
  • Continual Improvement: Continuously enhanced the QMS through regular reviews, audits, and corrective actions.

Benefits of Implementing ISO 13485:2016

  • Regulatory Compliance: Demonstrate compliance with regulatory essential for medical devices.
  • Enhanced Quality: Enhanced the quality of medical devices and minimize the risk of defects.
  • Enhanced Customer Satisfaction: Enhanced customer satisfaction through effective quality management.
  • Minimize Risk: Minimize the risk of product recalls, regulatory fines, and reputational damage.
  • Competitive edge: Differentiate your organization from competitors by demonstrating your commitment to quality and regulatory compliance.

Industries that Require ISO 13485:2016

  • Medical Device Manufacturers: Companies that design, develop, and manufacture medical devices.
  • Medical Device Distributors: Companies that distribute medical devices.
  • Medical Device Importers: Companies that import medical devices.
  • Medical Device Service Providers: Companies that provide services related to medical devices, such as maintenance and repair.