Let us be a collaborative author for your  development documentation.

Regulatory Submissions

  • Marketing Applications
    • Examples: 510k & PMA
  • Clinical Trial Applications
    • Examples: IDE & IND
  • Requests for Designation
  • Risk Determinations
  • Meeting Requests

Clinical Documentation

  • Design Plans
  • Study Protocols
  • Investigator Brochures
  • Validation Reports
  • Clinical Reports
  • Case Report Forms
  • Informed Consent Forms

Quality Management Systems

  • Standard Operating Procedures (SOPs)
  • Quality Policies
  • Work Instructions
  • Quality Control Metrics
  • Procedure Documentation

Scientific Publications

  • Journal Articles
  • Review Articles
  • Posters & Abstracts
  • White Papers
  • Backgrounders
  • Presentations
  • Blog Posts

Ready to find out more?

Contact us today with questions or to discuss your project.