Exceptional Medical Device Documentation – Your Partner for Regulatory Excellence
Revolutionizing Medical Device Documentation
Embark on a journey of precision with Wing Group, LLC – Your foremost partner in medical device technical writing. Our extensive experience extends to both the US (FDA) and European Economic Area (EEA)/Conformitè Europëenne (CE) Marking distribution requirements.
Expert Deliverables
Experience a comprehensive spectrum of medical device documentation solutions, meticulously designed to meet the demands of the industry:
- 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’re adept at navigating the intricate landscape of 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
- EU MDR: European Union Medical Device Regulation
- 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
Empower Your Communication
Partner with Wing Group, LLC, to transform your medical device communication strategy. Our dedication to regulatory excellence ensures your documentation meets the highest industry standards, empowering your brand’s credibility and safety.
Forge the path to excellence in medical device documentation. Contact Wing Group, LLC today.