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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 for Medical Device Manuals

Medical device manuals have become a vital tool in the healthcare industry. 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, or medical device manuals, so that the patient or caregiver can effectively use their medical device. 

What a Technical Writer can do for you

Technical writer for API documentaion

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

a stethoscope pressed to an arm, representing the importance of healthcare SOPs

Medical device manuals 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. 

Benefits of Using Medical Device Manuals

Using medical device manuals offer several benefits, both for healthcare professionals and patients. Here are some of the advantages:

  1. Clear instructions: A medical device manual provides clear and concise instructions on how to properly use the device. It outlines step-by-step procedures, safety precautions, and any specific requirements or considerations. This clarity helps users understand how to operate the device effectively and safely.

  2. User guidance: Medical device manuals often include user guidance and best practices for optimizing the performance of the medical device. They may provide tips, troubleshooting advice, and recommendations to enhance the user experience and achieve better results.

  3. Safety and risk management: Medical device manuals highlight safety precautions and warnings associated with device usage. They inform users about potential risks, contraindications, and proper handling procedures to minimize the chances of accidents or adverse events. Following the guidelines in the manual promotes patient safety and risk management.

  4. Standardization: Manuals contribute to standardization in healthcare practices. They establish consistent procedures for using the device, ensuring that healthcare professionals across different settings follow a uniform approach. This helps prevent errors, enhances efficiency, and promotes reliable outcomes.

  5. Regulatory compliance: Medical device manuals often include information to assist users in meeting regulatory requirements. They may contain instructions on documentation, calibration, maintenance, and quality control measures necessary to comply with relevant regulatory standards, such as those set by the Food and Drug Administration (FDA).

  6. Training and education: Manuals serve as valuable training resources for healthcare professionals who are learning to use a new medical device. They provide comprehensive information about device features, functionality, and applications, allowing users to develop the necessary skills and knowledge required for effective utilization.

  7. Troubleshooting and support: In case of device malfunctions or unexpected issues, manuals offer troubleshooting guidance. They provide a systematic approach to identifying and resolving problems, reducing downtime and the need for external support. Manuals may also include contact information for technical support or customer service, allowing users to seek assistance when necessary.

  8. Patient empowerment: For patients using certain medical devices at home, medical device manuals empower them by providing essential information about device operation, maintenance, and potential side effects. This knowledge enables patients to take an active role in their own healthcare, fostering self-care and independence.

Overall, medical device manuals play a crucial role in ensuring the safe and effective use of medical devices, promoting standardization, and empowering both healthcare professionals and patients. By hiring technical medical writers, who are trained in promoting a variety of different types of documentation, you will have an outstanding manual that us both user-friendly and effective. 


Clear and thorough medical device 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-friendly medical device manuals 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 

Essential Data Corporation

Whether you need a single technical writer for a brief project or a team of consultants to produce a complete line of documentation, the quality of our work is guaranteed for you. Our clients work closely with an Engagement Manager from one of our 30 local offices for the entire length of your project at no additional cost. Contact us at (800) 221-0093 or to get started.

Written by Diana Guerra