Practical Guide for Implementing Software Validation in Medical Devices: From FDA Guidance to Real-World Application – Part I

March 7, 2023 Michelle Wu

Software Validation, Medical Device

Practical Guide for Implementing Software Validation in Medical Devices: From FDA Guidance to Real-World Application – Part I


This is Part 1 of a 2-part series on software validation and computer software assurance in the medical device industry.

While it is clear that software validation is required by regulation in the US and elsewhere (e.g., the EU (European Union)), as regulated by the MDR and IVDR), how to execute continues to cause challenges, both for established medical device companies, and those just entering the medical device industry.

Between the different types of software, variations in terminology, type, and source of software (developed in-house, or purchased OTS, customized OTS (COTS), SOUP, etc.) advances in software technology, and evolving guidance of the FDA (Food and Drug Administration) and other regulatory bodies, it’s no wonder that implementation of software validation practices and procedures causes confusion.

This blog outlines the top things to know about software validation and computer software assurance as you implement practices and procedures for your organization in a way that is compliant and brings value.

Are you building or updating your software validation practices and procedures? If so, read on!

Top Things to Know About Software Validation and Computer Software Assurance

#1. Yes, there are different terms, methods, and definitions for software validation.

For the purposes of this blog, we’ll use the FDA’s definition of software validation, from their 2002 guidance. The FDA considers software validation to be “confirmation by examination and provision of objective evidence that software specifications conform to user needs and intended uses, and that the particular requirements implemented through software can be consistently fulfilled.”

At a high level, this makes sense. The confusion starts when folks try to define how that confirmation is performed and documented. How do I determine and document the requirements? How detailed do I need to go to my user needs and intended uses? For each feature? What kind of objective evidence? What if I’m using software to automate test scripts? Do I have to qualify the testing software? Turning to guidance and standards for a “standard” set of practices can add to the confusion. Even within just the medical device industry, there are multiple regulations and standards that use similar and at the same time, slightly different concepts and terminology. Examples include the IQ/OQ/PQ (Installation Qualification / Operational Qualification / Performance Qualification) analogy from process validation, black box testing, unit testing, just to name a few.

Before getting overwhelmed, take a breath and read on to point #2.

RELATED: How to Use Requirements Management as an Anchor to Establish Live Traceability in Systems Engineering

#2. Start with the regulations and standards.

While the multiple regulations and standards around software validation cause confusion, they are also a good place to start. I say that because at a high level they are trying to achieve the same thing- software that meets its intended use and maintains a validated state. Keeping the intent in mind can make it easier (at least it does for me) to see the similarities in the lower-level requirements between any terminology differences and not be as focused on making all the terminology match.

To start, select those regulations and guidance from one of your primary regulatory jurisdictions (like the FDA for the US). In the US, three main FDA guidance documents to incorporate are 1) General Principles of Software Validation; Final Guidance for Industry and FDA Staff, issued in 2002; 2) Part 11, Electronic Records; Electronic Signatures – Scope and Application, issued in 2003.

The 3rd guidance is relatively new, a draft guidance released in September, 2022, Computer Software Assurance for Production and Quality System Software. While in draft form, the final form for most guidance typically mirrors the draft document. The 2022 supplements the 2002 guidance, except it will supersede Section 6 (“Validation of Automated Process Equipment and Quality System Software”). It is also in this guidance that the FDA uses the term computer software assurance and defines it as a “risk-based approach to establish confidence in the automation used for production or quality systems.”

Once you’ve grounded yourself in one set, then you can compare and add on, as necessary, requirements for other regulatory jurisdictions. Again, focus on specific requirements that are different and where the high-level intent is similar. For example, in the EU, Regulation (EU) 2021/2226 outlines when instructions for use (IFUs) may be presented in electronic format and the requirements for the website and eIFUs presented.

#3. Start on the intended use and make your software validation and computer software assurance activities risk based.

Start with documenting the intended use of the software and associated safety risk if it were to fail. Then define the level of effort and combination of various software validation activities commensurate with the risk. Software and software features that would result in severe safety risk if it fails are to be validated more rigorously and have more software assurance activities than software that poses no safety risk.

Here are some examples of intended use and the associated safety risk.

Example 1: Jama Connect®, Requirements Management Software

Intended Use: The intended use of Jama Connect is to manage requirements and the corresponding traceability. The following design control aspects are managed within Jama Connect, user needs, design inputs, and traceability to design outputs, verification and validation activities. Risk analysis is also managed in Jama Connect.

Feature 1 Intended Use: Jama Connect provides visual indicators to highlight breaks in traceability. For example, when a user need is not linked to a design input, or vice versa.

Risk-based analysis of Feature 1: Failure of the visual indicator would result in the possibility of not establishing full traceability or missing establishment of a design control element like a design input. This risk is considered moderate as manual review of the traceability matrix is also performed as required by the Design Control SOP. Reports are exported from Jama Connect as pdfs, reviewed externally to the software, and then approved per the document control SOP.

RELATED: Traceability Score™ – An Empirical Way to Reduce the Risk of Late Requirements

Example 2: Imbedded software in automated production equipment

Intended use: The intended use of the software is to control production equipment designed to pick in place two components and weld them together.

Risk-based analysis: This is a critical weld that affects patient safety if not performed to specification. Thus, the software is considered high risk.

#4. Software Validation and computer software assurance is just one part of the software life cycle… you need to be concerned about the whole lifecycle.

There is more to software development and management than just the validation. Incorporate how custom software will be developed, how purchased software will be assessed to determine the appropriate controls based on risk, including verification and validation activities, and revision controlled.

#5. Have different procedures and practices for the different types of software.

This is a good time to consider how different types of software in your organization will be managed, and it’s not a one-size fits all approach. A best practice is to have separate practices and procedures; one for software in a medical device (SiMD) and software as a medical device (SaMD) and at least one other procedure and set of practices for other software, like software used in the production of a device, software in computers and automated data processing systems used as part of medical device production, or software used in implementation of the device manufacturer’s quality system.


Stay tuned for Part 2 of this 2-part blog series, where we’ll dive deeper into computer software assurance, highlight the risk-based approach, and provide tips and tools to manage your software in a compliant and efficient manner.

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