Documentation
Concise and thorough product documentation is key to any project's success. Whether you are developing your concept or want a documentation review, TriE can help.
Good documentation is the foundation to all medical devices. TriE knows the importance of this and provides quality documentation at every phase in the design process. Our documentation ensures full traceability of your design. At the completion of all projects a documentation package is transferred to our clients and TriE maintains copies within our quality system.
Whether you need some assembly drawings, assistance with a user’s manual, or need full product documentation, we can assist you. TriE’s documentation services include:
- 510(k) and FDA Submissions
- Design Requirements
- Design Specifications
- Failure Mode Effects Analysis
- Assembly Drawings
- Test Protocols/Study Reports
- Product User Guides/Quick Reference Guides
- Validation Documentation
- Device Master Record
- Device History Record
- Training Manuals/Training Presentations
- Service Manuals
- Manufacturing Documentation
Contact the TriE team to get started!