Wherever the art of medicine is loved, there is also a love of humanity.
— Hippocrates

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 Designation applications for Expedited Access Pathway

  • Investigational Device Exemptions (IDEs)

  • Small Business Qualification Certification

Regulatory Submissions - EU

  • CE Marking for Class I, IIa and IIb medical devices

  • Technical file generation

Strategic Advisory Guidance

  • Submission review (US or EU submissions)

  • Refuse To Accept or Hold Letter remediation

  • Help secure venture capital

  • Timeline assistance to approval/clearance

  • Device registration and listing

Marketing & Labeling Compliance

  • Claims review

  • Instructions for Use (IFU) translation

  • Essential labeling components

  • Unique Device Identification (UDI)