Services

Regulatory technical writing and editing

  • 510(k)s & PMAs
  • IDEs and supplements
  • Technical/design dossiers
  • Ethics committee submissions & investigator brochures

Quality technical writing and editing

  • Procedures, work instructions and forms
  • Study protocols and reports

Clinical technical writing and editing

  • Systematic literature reviews (click here for more info)
  • Literature searches
  • User manuals/IFUs
  • Clinical evaluation reports (CER)
  • Clinical protocols and reports

Other technical and creative writing and editing

  • Abstracts and articles
  • Training presentations
  • Brochures
  • Newsletters

Quality Management Systems

  • Design and development of FDA & ISO quality systems
  • Quality audits (QSR, ISO, GLP, etc.)