Medical Device Instructions for Use

Instructions for Use Are Key to FDA Compliance and Product Launch
Instructions for Use are an early building block in the rollout of your new medical device, but they’re far more than just a necessary step. Instructions for Use can help to:

  • Meet premarket notification requirements
  • Ensure accurate product usage
  • Ensure patient safety
  • Deliver reliable results
  • Reduce service costs
  • Increase buyer satisfaction

Instructions for Use format and length vary greatly depending on your product, intended use, and complexity. Novatek has worked with medical device companies for over 25 years to ensure that product documentation like Instructions for Use are user-friendly and meet your business, customer, and compliance needs.

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