Quality Systems and Regulatory Compliance

“It is the policy of Contour Fabricators, Inc. to satisfy our customers’ expectations for quality, delivery, and service while maintaining the effectiveness of the quality management system.”

ISO 13485:2003 CE Mark

FDA-registered medical device manufacturer
ISO 13485:2003 CE Mark Certified Establishment number: 1825560

FDA and ISO audits are a fundamentally necessary part of the medical device regulatory system. CFI Medical Solutions participation in third-party audits provides our customers with additional verification of our commitment to product quality and regulatory compliance.

CFI Medical Solutions has had the following FDA and ISO audits since 2003:

  1. ISO January 30-31, 2003
  2. FDA February 5-7, 2003
  3. ISO February 24, 2004
  4. ISO January 6, 2006
  5. ISO March 7, 2007
  6. ISO November 7-9, 2007
  7. ISO July 7, 2008