Our Services

"In a landscape of evolving regulations, our services are designed to keep you ahead. We prioritize accuracy and adherence, building trust with every client."

Regulatory Submissions - US

  • 510(k) Premarket Notifications

  • De Novo Applications

  • Premarket Approvals (PMAs) for Class III devices

  • Request for Designations (RFDs) or Pre-RFDs for Combination Products

  • Pre-Submissions (Q-Sub) for FDA feedback

  • Breakthrough Device & STeP Designation

  • Investigational Device Exemptions (IDEs)

  • 513(g) Request for Information (Classification)

  • General Wellness

Strategic Advisory Guidance

  • Submission review (US submissions)

  • eSTAR

  • Timeline assistance to approval/clearance

  • Device registration and listing

  • Regulatory Strategy

  • Standards and Regulatory Gap Analysis and Assessments

  • Risk Management, Design Control, Procedures, and Quality System Document Creation and Updates

  • Change Control, Memorandum-to-File, Letter-to-File Documentation, Catch-Up 510(k)

Marketing & Labeling Compliance

  • Claims review

  • Instructions for Use (IFU) translation

  • Essential labeling components

  • Unique Device Identification (UDI)

Contact us

Interested in working together? Fill out some info and we will be in touch shortly. We can’t wait to hear from you!