ISO 13485

PAJ GROUP - Advanced Mechatronics



ISO 13485


ISO 13485 is the fundamental standard within medical devices. PAJ is able to develop products and manufacture according to ISO 13485.


ISO 13485 consists of:


  • Monitoring of regulations
  • Control of work environment to ensure product safety
  • Focus on risk management
  • A range of specific product requirements


The advantages of ISO 13485 are:


  • Safe medical equipment
  • Ensurance that product lives up to all regulations
  • Use of best practises in the product development


PAJ is always ready for a detailed dialogue regarding a potential project, demanding development or manufacturing according to ISO 13485.


ISO9001 - ISO14001 - ISO13485 - IRIS - IEC61340-5-1 - IPC A-610 CLASS 3


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