Medical Device Guide & Checklist
The 10 Essentials for Writing a Clear Product Requirements Document
Executive Summary
The “Medical Device Guide & Checklist” is an essential tool for professionals involved in the development of medical devices. This document illustrates how to craft precise and effective product requirements documents (PRDs), a crucial document for regulatory compliance and successful project execution. It summarizes these insights in the provided comprehensive checklist to ensure that all critical aspects of requirement writing are covered.
By reading this guide, you will learn the importance of specificity, clarity, and consistency in your documentation. These skills are vital for reducing development risks, facilitating smoother collaboration among cross-functional teams, and ensuring your PRDs can withstand regulatory scrutiny. The guide’s practical tips and examples will help you create robust requirements that lead to better-designed products and more efficient development processes.
1. DEFINE REQUIREMENTS IN MEASURABLE TERMS
When writing a medical device essential requirements checklist, it is important to keep in mind that you must be able to demonstrate how the requirement is met. If you cannot quickly come up with an objective way to show that the requirement has been met, it probably needs to be rewritten. Requirements should be written so that they contain a clearly measurable objective. A person unfamiliar with the product or process should be able to come in and verify requirements are met through a review of documentation.
Remember, if it isn’t documented then it didn’t happen!
2. ENSURE EACH REQUIREMENT IS SPECIFIC
Broad requirements are weak and difficult to verify. One way to make sure that your requirements are specific is to eliminate the use of inherently weak words such as user-friendly, reliable, capable, etc. These words are vague and do not tell the user what is being measured (see Tip #2). Your medical device requirements specifications should be able to standalone without supplementary information to explain what “user-friendly” or other broad terms mean.
“The device must be user-friendly” – This is a weak requirement that leaves many questions unanswered. How is “user-friendly” defined? Who are the users? Is this talking about the user-interface, ergonomics, or other features that the user interacts with?
Instead, this requirement should be broken down into a series of small, objective requirements.
3. USE IMPERATIVES SUCH AS “SHALL” OR “MUST” PROPERLY AND CONSISTENTLY
Anyone that works in the Quality or Regulatory side of medical device is well-versed in reading standards and regulatory requirements like ISO 13485 closely for shall and should statements. Your requirements document should not require a close reading to determine intent.
The device must interface with common accessories. – This reads as non-negotiable, it MUST interface
The device should interface with common accessories. – This reads an optional or nice to have feature
4. ENFORCE CONSISTENCY OF TERMINOLOGY AND PROHIBIT INDUSTRY OR COMPANY JARGON
Sticking with consistent terminology makes it easier to search through requirements quickly and minimizes the risk of incorrect interpretation. It may be helpful to include a definitions or glossary section to the requirements document if conflicting terminology is a consistent concern or the requirements document will be used by personnel that may be downstream in the process and use different terminology.
This also includes consistently referring to acronyms or abbreviations. Acronyms are only useful when they are standardized and understood by all document users. Your medical device requirements specification needs to be easily understood by all personnel that may work with it.
Interested in learning more on writing clear product requirements in the medical field? Download our guide to continue reading!
