ISO 13485 is the medical industry’s optimal device standard, which ensures that all medical devices meet the proper regulatory compliance laws and customer needs. ISO 13485 certification is a valuable credential put in place to keep professionals and customers safe in clinics, hospitals and other medical settings.

Adopting ISO 13485 provides a practical foundation for manufacturers to address the EU Medical Device Directive (MDD), the EU Medical Device Regulation (MDR), and other regulations, as well as demonstrating a commitment to the safety and quality of medical devices.

Requirements of ISO 13485

  • Documentation requirements for medical device files
  • Production requirements for cleanliness of products
  • Work environment requirements

  • Production requirements for sterile medical devices
  • Contamination control requirements

  • Requirements for reporting to regulatory authorities

Benefits of ISO 13485

  • Ability to contract with larger companies
  • A defined process for effective risk analysis
  • Demonstrate commitment to high quality
  • Help staff access relevant Information
  • Expand potential market
  • Meet the complete product requirement by the customers
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