• Regulatory strategy (regulatory research, initial FDA contacts, pre-submissions, device classification, writing, submitting and supporting your regulatory submission)
  • Regulatory submissions: US FDA, EU, Canada
  • Product labeling and packaging development and/or review
  • Coordinate product testing (biocompatibility, electrical safety/EMC, biocompatibility, sterilization validation)
  • Regulatory intelligence and guidance interpretation

Quality Systems/Compliance:

  • Quality System design and implementation
  • Internal audits
  • Assist with third-party inspections/audits (US FDA, ISO)
  • Post-market Compliance communications: Responses to 483s and Warning Letters, Field Actions (recalls, market withdrawals, field corrections), MDR/Adverse Event reporting
  • Training: develop training materials, coordinate/deliver employee training sessions

Design Control:

  • Develop/review/audit Design History Files, Technical Files, Design Dossiers
  • Testing coordination: Electrical safety, materials characterization, biocompatibility, shipping/packaging

Clinical Studies:

  • Clinical trial strategy, protocol development and/or review
  • IRB submissions
  • Clinical trial monitoring

Contact Information:

SJR Associates

Phone: +1 541.683.3017