ISO 13485

PAJ GROUP - Advanced Mechatronics

MEDICAL

DEVICES

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.

WE BELIEVE IN QUALITY

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

 

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