We have many years of experience developing documentation for medical devices and medical diagnostic equipment. We understand FDA 801 guidelines and requirements for product labeling. We are experienced with complex electromechanical devices and related software.
We know how to "Write it, Right" when it comes to:
- Instructions for Use (IFU)
- Patient Manuals
- Clinician Manuals
- Quick-reference Guides
- Quick-start Guides
- Setup and Installation Manuals
- Service and Maintenance Manuals and Procedures
- Medical Device Software Documentation including online help systems
- Directions for use
We also have Quality and Regulatory Compliance experts who can assist you with
- 510K submissions
- Specific FDA labeling requirements
- cGMP and ISO requirements and documentation
We are experienced with the software you use, including Adobe® FrameMaker® and InDesign®.
We have writers who can do the research (Literature Route and/or Clinical Investigation Route) and develop your Clinical Evaluation Reports (CERs).
We also have experience developing Commissioning and Qualification (C&Q) Validation Documentation.
Having one company with the expertise to handle all the above lets you benefit from our team approach. Our writers can easily work closely with Quality and Compliance experts to ensure you get the best outcome.
We also understand while you can fullfill the basic requirements that often doesn't mean the patient, medical professional, or lab worker is getting documentation that is easy to understand or use. Many companies' help lines are overused because their documentation is simply not being read because either the instructions are too difficult to follow or the information needed isn't readily found. We understand that and we draw upon our experience to develop and design documentation that is both easy to use and understand. Depending on the scope of the project, we can work with your human factors consultants or our's, and engage focus groups to ensure you are getting the best possible documentation through testing and verification.
If your products reach global markets, rest assured we also have the experience with translating and localizing documentation into as many as 21 different languages.
Contact us at firstname.lastname@example.org for a free consultation. Or call 1-800-985-7701. We will show you how to improve your content processes–and increase your productivity.
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