Why ISO 13485 and CE Marking required for International Business?

The below mentioned are the major reasons:

  • European Union Regulatory requirement
  • Global markets recognized ISO 13485 and CE Mark
  • ISO 13485 ensures consistent quality
  • ISO 13485 to ensure patient safety and timely access to medical device technologies across globe.
  • ISO 13485 conformity assessment and Certification are recognized and accepted worldwide.
  • Harmonized Quality Management Systems (ISO 13485:2003) is critical to global medical trade.
  • Most country specific Medical Device Regulations are harmonized with ISO 13485
  • The QMS of choice is ISO 13485:2003 and most Medical Device Regulations need it.
  • European Council accepts ISO 13485 for Annex II CE marking as per  93/42/EEC +2007/47/EC
  • US FDA 21 CFR Part 820 is in line with ISO 13485
  • ISO 13485 is a powerful Quality Management System standard
  • Finally, Regulatory authorities in more countries insist ISO 13485 based QMS for regulatory purposes.

Read More about ISO 13485

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