We are here to help you solve the problems you have encountered in bringing your medical devices to market.  We have the experience to help you with:
  • Regulatory submissions
  • Quality Management System set-up
  • Regulatory Information Management
  • Design Compliance
  • Developing marketing collateral
  • Implementing Unique Device Identification
  • Remediation Services
  • Usability studies
  • Human Factors
  • Developing Distribution Channels
  • Sourcing products
  • Reimbursement
  • US Agent/Correspondent Services
Our Associates have over 100 year's combined experience in the medical device

industry.  We have worked with small to large device manufacturers.  We know the issues you face in bringing your products to market.  We know how to navigate these issues, to help you solve them, and to help you put into place systems that help you avoid these problems in the future.

We are constantly updating our knowledge base staying on top of the latest regulations that will impact our clients:
  • IEC 60601-1 3rd Edition
  • RoHS
  • Unique Device Identifier rule
  • And more…

Partnering with our clients, we work to become trusted advisors not only for regulatory issues, but also how they impact their business in general.  We can do the same for you.
“Your success in life isn’t based on your ability to simply change.  It is based on your ability to change faster than your competition, customers and business.”
                                                                                                                               - Mark Sanborn