Services

Regulatory Strategy & Submissions FDA Class I & II

  • Medical Device Classification & regulatory pathway determination
  • Regulatory strategy & positioning (incl. General Wellness, borderline products)
  • Q‑Submissions: Pre‑subs, SIRs, other FDA interactions
  • 510(k) submissions: Traditional, Special, Abbreviated
  • Post‑submission support: RTA, AI, NSE remediation
  • De Novo submissions
  • 513(g) Classification Requests
  • Breakthrough & STeP / Sprint programs
  • FDA Registration & Device Listing; U.S. Agent services
  • LDT & CDS regulatory strategy; CLIA waivers
  • Letter to File
Regulatory roadmaps and submission planning

Non‑Clinical Bench Testing

  • Benchtop testing plan and strategy
  • Integration of design & special controls with testing plans
Benchtop testing in a lab setting

Quality Management Systems (QMS) & Compliance

  • QMS development and implementation
  • Gap analysis
  • Internal audits, remediation, and FDA readiness
Quality system documentation and audit readiness

Human Factors Engineering

  • Formative & summative usability testing protocols
  • Human factors documentation
Human factors usability testing session

Project Management

  • Oversight of regulatory & quality projects
  • Progress & budget tracking in PM software
  • Document collaboration & tracking systems
  • Biweekly alignment meetings
  • Small Business Designation support for reduced FDA fees
Milestone tracking and cross‑functional planning