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ISO 13485

The medical industry is one where quality and reliability is critical, lives can depend upon it. Medical device manufacturers need to be confident that they are dealing with a contractor who understands the additional regulatory requirements for medical devices, ISO 9001 certification may not always be sufficient.

Jaltek are one of the few UK-based CEMs to hold both Aerospace (AS9100) and Medical (ISO 13485) Quality Management certifications.

The ISO 13485 Quality Management standard is aimed specifically at medical devices and the associated regulatory compliance requirements. The standard requires a more thoroughly documented quality management system than the ISO 9001 certification. There is also an emphasis on safety and managing risk; foreseeing and fixing problems before they occur.

Jaltek’s ISO 13485 certification demonstrates our commitment to meeting the requirements of the medical device sector including:

  • Record keeping
  • Device history records
  • Supply chain evaluation
  • Material traceability
  • Product and process verification

We can work with you to help meet the standards of the European Medical Devices Directives and U.S. Food & Drug Administration’s Quality System Regulations. Please get in touch for more information on how we may help you be compliant.