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