ISO 13485 Certification for Medical Device Manufacturers

ISO 13485:2003 is a quality system standard designed specifically for medical device companies, its Benefits of Certification For manufacturers of medical devices who want to provide safe/effective equipment, a proper Quality Management System (QMS) needs to be in place in order to comply with regulatory requirements. The ISO 13485 standard has many of the same requirements as ISO 9001:2008. However, there are additional requirements for process control, design control, retention of records, accountability, traceability, customer feedback and more.

Benefits of ISO 13485 Medical Devices
  • Increase the probability of making safe and effective medical devices
  • Increase access to more markets worldwide with certification
  • Meet regulatory requirements and customer expectations
  • Demonstrate that you produce safer and more effective medical devices
Additional Benefits of ISO 13485 certification:
  • Increased Efficiency
  • Cost Savings
  • More Effective Risk Management and Quality Assurance
  • Improved ability to respond to Customer Requirements

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ISO 9001: 2015 Certification, ISO 14001:2015 Certification.