Fieldstone Consultants provides strategic and tactical support for Medical Device Quality Assurance and Regulatory Affairs activities. With over twenty years of industry experience and a foundation in Quality Systems Management and FDA Regulations, we have the ability and expertise to help you navigate the Medical Device landscape.  Whether your organization is just beginning its journey or has an established Quality System and needs right-sized solutions, give us a call.

With extensive experience leading teams, organizations, and projects to success. Our capacities include Quality System Management, Regulatory Affairs, New Product Development, Risk Management, Quality Control, and Process Improvement. Our focus is on efficient outcomes and prioritization of safety and quality

We provide comprehensive end-to-end quality and regulatory services and are committed to delivering accurate guidance and consultation while navigating regulatory processes.

Fieldstone can help you and your product make a difference.