ISO 13485 Consulting

Our products are designed so that you can use them as a do-it-yourself implementation tool. However, we know that sometimes you might want to consult an expert to help you on your project for a portion of it. We recommend the following consultants:

Methodize, Inc.

  • Methodize Inc. has over 35 years of combined Regulatory, Quality, and Clinical services. Internationally recognized, Methodize Inc. has helped companies all over the world in bringing medical devices and In-Vitro Diagnostics products to market.
  • Our mission is to provide our clients knowledge, integrity, and services to successfully take their products to market.
  • We are located in Minneapolis, MN and provide our products and services to countries and industries around the world.

Areas of Expertise

  • CE Marking Consulting
  • ISO 13485 & ISO 9001 Certification
  • ISO 14971 Risk Analysis
  • Clinical Trials US
  • EU & International
  • Authorized European Representative


  • Phone consulting
  • On-site consulting
  • Training
  • Internal Auditing
  • 3 Hour Consulting Package, available with purchase of the Small Business Package or the All-in-One Package, $260.00 Add To Cart
  • 6 Hour Document Review Package, $560.00 Add To Cart
  • International Wire Transfer


ISO 9001 All in One Package