Our experts are available when needed to:
- Advise you on medical device regulatory requirements.
- Evaluate the classification of your medical device.
- Determine the proper FDA product code and regulation number.
- Select the proper predicate device for your 510k submission.
- Implement a Quality Management System(QMS)
- Review device labeling.
- Advise you on import/export regulations.
- Review and respond to FDA letters.