Medical Device Documentation

We have medical device technical writing experience for US (FDA) and European Economic Area (EEA)/Conformitè Europëenne (CE) Marking distribution.


Our medical device documentation products include:

  • Instructions for Use (IFU)
  • Operator’s Manuals
  • User Manuals
  • Service Manuals
  • Clinical Trials Investigator Manuals
  • Data Sheets
  • Package Inserts
  • Supplements
  • Standard Operating Procedures

Standards, Regulations, and Directives

We have experience with medical device standards, regulations, and directives including:

  • AAMI: Association for the Advancement of Medical Instrumentation
  • ANSI: American National Standards Institute
  • ASTM: American Society for Testing and Materials
  • EEC: European Economic Community
  • EN: European Standard
  • IEC: International Electrotechnical Commission
  • FCC: Federal Communications Commission
  • ISED: Innovation, Science and Economic Development
  • ISO: International Organization for Standardization
  • RoHS: Reduction of Hazardous Substances
  • UL: Underwriters Laboratories

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