Paladin Medical, Inc.

P.O. Box 560
Stillwater, MN 55082
Phone: (715) 549-6035
FAX: (715) 549-5380
Contact: Elaine Duncan, President

Paladin Medical Homepage

Biomedical Field

Regulatory consulting




  • Regulatory strategy and planning

  • Pre-submission meetings with the U.S. Food and Drug Administration (FDA)

  • Total Quality System implementation (GMP/ISO)

  • Hazard (Risk) analysis (e.g. FMEA, FTA)

  • Design control and review procedures

  • Pre-clinical in-vitro and in-vivo protocol design

  • Biomaterials selection and biocompatibility qualification

  • Combination products and surface modified devices

  • Investigational device exemption applications

  • Clinical study design, monitoring and management

  • Pre-market notifications

  • Pre-market approval submissions, supplements, reports

  • Product development protocols

  • Technical construction files and conformity declarations

  • International regulatory submissions and exports