A person that needs a medical device manual in trying to understand how to use a blood glucose meter to check their blood sugar

The Need or Medical Device Manuals

Technological development in the medical device industry has allowed for the growth of devices meant for use by the patient, caregiver, or qualified healthcare professional. With the growing aging population, there has been more of a move towards home healthcare. Innovations in technology include the use of such medical devices as infusion pumps, ventilators, and wound care therapies. However, there comes a risk of improper usage of medical devices due to a lack of training. Improper use can result in detrimental effects on the health of the patient. For this reason, it is imperative that medical devices come with proper and well-written instruction manuals so that the patient or caregiver can effectively use their medical device. 

What a Technical Writer can do for you

The FDA has specific outlines on what instruction manuals should look like for medical devices. There are a variety of factors to consider in the instructions for the use of medical devices. This includes the purpose of the device, when it should and should not be used, how to maintain it or dispose of it, how to set up the device, and more. The FDA recommends that instructions for the use of medical devices must be thorough but written in layman’s terms. Given that medical device usage may come with a lot of technical languages it can be difficult to produce an instruction manual that is comprehensive yet easy to follow. Technical writers are adept at taking in technical information and creating user guides that are simple enough for anyone to understand. This is of utmost importance when it comes to using medical devices outside of a hospital setting. 

What goes into a Medical Device Instruction Manual?

In order to produce a thorough instruction manual for medical devices, there needs to be a specific format. The FDA format generally accepts and includes the format below in sequential order:

  • Table of contents
  • Glossary (to define medical terms)
  • Purpose of the device
  • Set up instructions
  • Operating instructions 
  • Importance of the need to monitor the activity of the device
  • Cleaning instructions 
  • Storage instructions 
  • Troubleshooting information 
  • Index
  • User assistance information 

A medical device instruction manual contains some of the sections above, but It can have more depending on the device. The user instructions for medical devices help assure knowledge on how to effectively use their medical devices. More importantly, a user must be aware of any device maintenance. The goal is for lengthy medical language instruction to be readable. Technical writers are experienced in the ability to take difficult language and convert it into content that is well understood by the layperson. 

FDA Requirements for Medical Device Instructions for use

Instruction manuals for medical devices must also follow regulations set forth by the FDA Food, Drug, and Cosmetic Act. This piece of legislation requires that medical devices must have labeling. They must include adequate instructions for use, operating and servicing instructions, and information necessary for the protection of the users. According to the FDA, misuse of a medical device is often tied back to inadequate directions for use as a result of manufacturers’ failure to fully address user needs.

Furthermore, compliance with the labeling requirements, which includes user instructions, is integral to getting a medical device to market. Furthermore, a patient or caregiver will be able to appreciate the simplicity of using a medical device. A manufacturer must also consider two questions. Who will be using the device? and how will it be used? to avoid issues. The manufacturer that is familiar with technical language may not realize that this language is not suitable for the layperson. In this regard, technical writers come in handy as they understand how to craft guides that are user-friendly and can simplify medical terminology and language without losing any vital information. 


Clear and thorough medical device instruction manuals are crucial to the proper usage and compliance with FDA regulations for medical device labeling. With the increasing development of medical devices meant for use at home, it is even more important for the user instructions to cater to the layperson. EDC’s technical writers are experienced in the production of successful user instructions that include accessible language, clear visuals, easy-to-follow steps, and enough information for the proper use of a product. With adequate instruction manuals, users will not have to rely so much on technical support and will help boost their confidence in the manufacturer of their medical device. 

How EDC can help 

Whether you need a team of consultants to produce a complete line of documentation or a single technical writer for a brief project, Essential Data’s Engagement Manager will lead the project from start to finish. At Essential Data Corporation, we guarantee the quality of our work. Contact us today to get started. (800) 221-0093 or sales@edc.us

Written by Diana Guerra