header photo

Acorn N Oakes LLC

Planting the seeds of Quality for Sustainable Business Growth

  • 21 CFR 820 and ISO 13485 Compliant Quality Systems, Customized for your small business needs
  • ISO 13485 Readiness Package (Preliminary review and mock audits to prepare your organization for the certification process)
  • FDA Submission preparation (Establishment Registration, Device Listing, 510(k) preparation)
  • FDA US Agent and/or Official Correspondent for foreign establishments
  • Design Controls maintenance and consulting
  • Regulatory strategy consulting