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ISO 13485 – Quality Management System for Medical Devices
About this service
ISO 13485 is specifically designed for the medical device industry to ensure that a company's quality management system meets regulatory requirements in various countries. This standard emphasizes risk management, production process control, and strict technical documentation. In practice, ISO 13485 is a critical requirement for medical device registration and distribution, including obtaining marketing authorization, and enhances the company's credibility in establishing cooperation with local and international partners.
What you get
Assistance in preparing quality system documents according to ISO 13485.
Gap analysis specific to the medical device industry.
Internal audit simulation to prepare for the official audit.
Technical consultation related to production processes and quality control.
Monitoring during the external audit.
ISO 13485 certificate as a global requirement for the medical device industry.
Requirements
Download AttachmentCompany administrative data.
Production process and quality management documents.
ISO 13485 quality manual.
Personnel data related to production and QA.
ISO 13485 self-assessment.
Records of medical device quality management system implementation.
