We provide medical device consulting services to medical device companies of all sizes. From 510k marketing clearance to FDA QSR / ISO 13485 compliant medical device quality systems to assistance with post market issues, we provide comprehensive medical device consulting solutions. FDA quality compliance can be a challenge. We help your medical device company effectively navigate the FDA compliance process and stay on track!

Our medical device consulting services are a valuable asset to your team. Whether their time is at a premium or access to needed expertise is limited, our medical device consulting services help your company meet FDA medical device requirements. Our services are available for specific projects or individual tasks. We can assist your team with 510k preparation or review, replying to 483s, determining appropriate corrective actions and deciding how to best comply with FDA medical device requirements. We can also identify appropriate suppliers, develop needed processes and help your company ensure overall quality and regulatory compliance. From medical device product development to post market surveillance, our medical device consulting services help your business navigate the medical device quality and regulatory compliance process. Medical device startup or small business clients are welcomed!

Call us today to discuss how we can meet your medical device consulting needs!