GLOBAL STRATEGY

• Create global regulatory strategy
• Determine device classifications
• Select predicate (if applicable)
• Propose Intended use / indications for use
• Identify unique country requirements
• Identify global clinical requirements
• Document submission dates
• Estimate global approval dates
• Identify potential risks and mitigations
• Plan distribution controls

REGULATORY SUBMISSIONS

• Plan, write, format, edit, review
  • US: 510(k), PMA, IDE, Supplements, AR
  • EU: Technical Files and Design Dossiers
  • Japan: Clinical trial, Shonin, and QMS
  • International submissions
• Communicate with reviewers
• Manage response strategy
• Write and review responses
• Correspond with international
• Create eCopy

TECHNICAL DOCUMENTATION

• Review protocols, reports and raw data
  • Design validation and verification
  • Shelf life and stability
  • Test methods
  • Chemistry, Manufacturing and Controls
  • Engineering and manufacturing documents
  • Pre-clinical and clinical studies
  • Biocompatibility
  • Sterilization

• Review product labeling
• Review advertising and promotion

PROJECT MANAGEMENT

• Work with program management
• Partner cross-functionally
• Build submission schedules
• Identify deliverables needed
• Track and manage project timelines
• Act as Regulatory Project Manager

CLINICAL

• Input to clinical trial design
• Input to clinical study protocol
• Prepare for pre-submission meetings
• Develop Investigator Brochure
• Prepare for investigator meeting
• Review clinical study report
• Review clinical evaluation report
• Support IDE and IND submissions
• Write periodic and annual reports

ADDITIONAL EXPERTISE

• Support audit preparation
• Address FDA warning letter
• Create and deliver training
• Create presentations
• Mentor regulatory staff
• Conduct research
• Write for your company website
• Write blog posts and newsletters
• Travel consulting and planning