From innovation to deployment

We help some of the world's most trusted brands and innovative startups deliver healthcare more effectively.

We work with inventors, physicians, and technicians to shape the future of healthcare.

Our work improves millions of lives annually and improves healthcare delivery on every continent.

OTC and Prescription Devices

  • Product assessment
  • Label Reviews
  • Product listing
  • GUDID filing

Clinical Medical Devices

  • 510k preparation and submission
  • Clinical trial design
  • Review and approval process oversight

Medical Software

  • ISO Compliance
  • Labeling Review
  • Documentation
  • 510k preparation and submission