Medical Devices

Patient Instructions For Medical Devices


Patient instructions

If a medication requires a medical device, patients must learn how to manage their medication as well as how to use the medical device correctly. A lack of proper understanding of how to use the medical device can lead to ineffective drug treatment. Not only must the patient understand how to administer and monitor their response to the medication, they must also be able to understand and follow the step-by-step instructions for the medical device.

The patient instructions for the medical device must be simple and easy to understand. They must be written in a logical order of use reinforced by clear photos and a good graphic design that will help increase patient recall.

Consumer Health Information Corporation has expertise in the development of patient instructions for medical devices at the following levels:

  • Collaboration with the research designers of the device to ensure that the device meets patient education needs. Our team has worked with design engineers on many different types of medical devices. Sometimes, simple changes such as the addition of color can help make the medical device more “patient-friendly”
  • Development of patient instructions for medical devices are submitted to FDA for approval as the official Patient Labeling for the device
  • Development of User Manuals for Product Starter Kits and product launches
  • Photoshoot direction. Determination of the photos required for patient comprehension and direction of photoshoots. Incorporation into a graphic design layout that meets patient education requirements. Complete production an option.

Our team develops the content of the medical device instructions very closely with the layout at all times. This ensures that the content and design reinforce each other and that photos/illustrations maximally increase patient recall.


Consumer health

Our Expertise in Patient Education Is Unmatched

Let us put our over 30 years experience developing patient education programs  to work for you! 

Our team has expertise in:
  • Developing a patient adherence strategy for the product
  • Developing all the patient information materials
  • Writing clinical information in an empathetic tone that patients can understand and relate to
  • Developing “patient-friendly” user manuals for medical devices
  • working with your Regulatory and Medical teams to submit to FDA with full documentation for speedy approval
  • Notarized translations in 104 languages that can be used internationally

Our team of patient education experts have years of experience counseling patients and have worked with pharma medical, legal, regulatory and marketing teams and FDA for the past 20 years. All of our materials are designed with a focus on patient compliance with the goal that patients will be motivated to manage their medications and medical devices safely and wisely.

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For a confidential consultation to discuss how to ensure that patients understand how to use your medical device correctly, give us a call today at (703) 734-0650.