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13485store.com The Tools You need to Achieve and Maintain ISO 13485 Certification 13485store.com The Tools You need to Achieve and Maintain ISO 13485 Certification 13485store.com The Tools You need to Achieve and Maintain ISO 13485 Certification
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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 Jack Slovick of Methodize Inc. as a consultant to assist you with your specific ISO 13485 questions.

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

Services

  • 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,



  • 6 Hour Document Review Package,

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