Our Services

It all began with an idea. You wanted change. You wanted different.

Fieldstone Consultants can help with that journey.

With real-world experience helping teams succeed, we have perspective and the ability to help meet your Regulatory Affairs, Quality Assurance and Compliance needs.

Quality Management Systems

  • Design Control and Risk Management

  • QMS Administration

  • Internal, External, and Supplier Audits and Support

  • CAPA Management

  • Personnel Training (QMS)

Regulatory Affairs & Submissions

  • Regulatory Strategy

  • Pre-Submission Application

  • Breakthrough Application

  • STeP Application

  • Premarket Submissions (De Novo, 510(k), and PMA)

  • U.S. agent services

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