IVD Medical Device Software Development and Regulations

by | 11. 04. 2022 | Software Development

Reading Time: 6 minutes

Software development is a crucial part of product development for IVD medical devices, and, in recent years, it is increasingly becoming a differentiator between competitive products.

It is essential to build software that enhances medical treatments and patient care while supporting the software users and helping them perform their work tasks simultaneously.

But first, we need to define the fundamental terminology in regulated environments such as IVD medical devices.

Definitions

Medical device

If a device is used to diagnose, care for, treat or prevent a disease or a condition in humans without the need for a chemical, immune or metabolic action happening first to achieve its primary purpose, a device is called a medical device.

IVD medical device

A particular sub-group of medical devices intended to diagnose a disease or condition or determine a response to a treatment based on a human specimen (e.g. blood, tissues, urine, etc.) is called in vitro diagnostic (IVD) medical device. These encompass reagents, kits, instruments, software and similar, used alone or in combination.

Software in IVD medical devices

Software may play different roles when it comes to IVD medical devices. It can be:

  • embedded software, i.e. firmware that is part of an IVD medical device and used to operate a device;
  • accessory to an IVD medical device, that is supplied separately from a device but is intended to operate or influence a device;
  • standalone software used to provide diagnostic or therapeutic information and is not intended to operate or influence an IVD medical device.

Regardless of its role, software must be intuitive and user friendly, allowing people to quickly understand how to use it or interact with an IVD medical device.

Since IVD medical devices provide insight into a patient’s disease or condition, they pose a certain risk for the patient or/and other people. The gravity of that risk largely depends on the device’s intended purpose. To ensure that IVD medical devices are safe and reliable, designing, developing, producing, and post-production of devices must follow certain regulations and standards.

Regulations and standards

IVD medical devices are a subject to different regulations and standards to ensure safety, higher quality and reliability of products, processes and services. However, there is a fundamental difference between the meaning and applications of standards and regulations.

Regulations – obligatory rules of order that are legally obligatory and are prepared and issued by authorized government agencies.

Standards – voluntary guidelines developed by regional, national or international standardization organizations.

If you are interested to learn more about standards and regulations, we invite you to read our article Digitalization – Understanding standards, regulations and guidelines.

Regulations and standards for IVD medical devices

There are many regulations and standards available for IVD medical devices, so your decision on which regulations and standards to follow for your IVD medical device largely depends on the market you wish to enter and the device’s classification on that market.

For IVD medical devices, there are different standards and regulations that you can decide on.  The three most widely used are:

  • ISO 13485: Medical devices — Quality management systems — Requirements for regulatory purposes
  • ISO 14971: Medical devices — Application of risk management to medical devices
  • IEC 62304: Medical device software – Software life cycle processes

Classification for IVD medical devices differs from country to country; there is one thing they have in common – i.e. devices are classified based on the risk posing to patients and other people with those posing lower risk being in lower (e.g. Class A/I) and those posing higher risk being in higher classes (e.g. Class D/IV).

You can download an extended version of this article with an in-depth explanation of standards and classification systems at the end of the blog article, if you wish to learn about:

  • what standards are used for IVD medical devices
  • what each of the standards represents
  • what classification systems are used in different countries

Software development for IVD medical devices

Whether software needs to comply with regulations and standards or not, the development of software follows a process divided into individual steps that are happening either consecutively or in parallel. The process is also referred to as a software development lifecycle.

Software development life cycle, in general, comprises of 7 steps, which are the following:

  • planning,
  • requirements analysis,
  • designing,
  • implementation of requirements and design,
  • testing,
  • deployment where fully built and tested software is released, and
  • maintenance.

The choice of the development model depends solely on the nature of the project. Different models of software development process have evolved over the years, for example, waterfall, V-model, agile, iterative, to name just a few.

For IVD medical device software, one of the suitable models is V-model. This model is an extension of a waterfall model where steps are performed sequentially in a V-shape (see Figure 1 below). For every step in the verification phase (left-hand side), there is a step in the validation phase (right-hand side). As of lately, the agile V-model has become a popular choice as well.

Figure 1: V-model of the software development process at BioSistemika

Documentation

The most significant difference in the development of the IVD medical device software and software for non-regulated environments is the extent of documentation that needs to be provided with the software.

What needs to be documented during the development process depends on:

  • regulations and standards you have to comply with,
  • the risk classification of the software,
  • type of the software (i.e. embedded, accessory, standalone), and
  • your role in manufacturing the IVD medical device (i.e. legal manufacturer or supplier).
  • Throughout the software development life cycle of an IVD medical device software, risk management has to be applied and tracked in the risk management file.

The main objective of these documents is traceability between software requirements and tests and between requirements and high- and low-level architectural design, which needs to be considered when preparing the documents.

For the development of accessory or standalone IVD medical devices, software needs to comply with IEC 62304. Each of the software development phases that we described has corresponding documentation.

You can review the list of documents, divided by each software life-cycle step and a corresponding document owner in our extended version of this article, which you can download below.

Download the whitepaper to access the extended version of the article, which includes:

  • a list of standards used for IVD medical devices,
  • an in-depth explanation of what each standard represents,
  • overview of classification systems that are used in different countries,
  • checklist of documents required in the process of IVD medical device software according to IEC 62304.

Why should you outsource IVD medical device software development?

In general, software development outsourcing, but especially in regulated environments, can be a successful strategy. It can fill the gaps in internal resources or add additional expertise that the technical team might lack.

What will you gain with outsourcing software development for IVD medical devices?

> Faster market access

With outsourcing software development, you will accelerate your product pipeline, so you will be able to get more products to the market in shorter time. In many cases, internal software teams are swamped with work while products are waiting in the pipeline. By outsourcing some of the projects, you will gain access to an external team that is ready to start working on your project so you can start selling sooner and bring in the revenue for the company.

> Keep your focus

Each company has their primary expertise that brings them success. If coding is not one of your strong suits, it is worth considering outsourcing the software development. With a trustworthy partner, you can continue working on the tasks in which you are the best, and they will complement it with other technical skills.

> Regulations expertises

Developing an IVD medical device requires know-how from different fields, and in some cases, it doesn’t make sense to have all this expertise in-house. For that purpose, outsourcing can be an easy solution to help fill these shortcomings. Since software development for IVD medical devices demands a deep understanding of regulations and documentation, outsourcing to an experienced partner can save you some problems later in the development.

If you want to learn more about why outsourcing software development is a good idea and learn some pro tips, you can read our article 6 reasons to outsource software development (with tips).

Summary

  • Software in an IVD medical device can be embedded software, accessory to a device or a standalone device.
  • To ensure the safety and reliability of IVD medical devices, all phases of the medical device life cycle need to follow regulations or/and standards.
  • The choice of the regulations and standards depends on the target market and risk classification of the IVD medical device on that market.
  • While the software development process for IVD medical device software and software for non-regulated environments follow the same steps, there is a big difference in the extent of documentation needed for the first.
  • Software development outsourcing can help you bring your product to the market faster, take the burden off your internal team or/and bring additional expertise into your product development.

Are you working in the IVD medical market and have a software development project in mind? Discover more about our expertise.

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