The Power of Documentation Software for Medical Device Manufacturers

Did you know the medical device industry is a global market expected to grow to $623 billion by 2026? Medical devices come in a variety of shapes and sizes, from hospital beds and elastic bandages for low-risk use to more complex and invasive pieces of equipment like MRIs, pacemakers, and X-ray machines. In fact, the FDA has classified over 1700 devices to date across three risk classes.

It’s a very competitive market and one that is highly regulated. Regardless of who the device is made for (patient, healthcare worker, other) or where it’s used (at home, in a hospital, or in a high-stress environment like the battlefield), these devices must be used correctly to ensure the patient’s safety and the effectiveness of the device. For these reasons and others, accurate and complete technical documentation is critical.

Let’s take some time to talk about the important technical documentation that is created for medical devices and look at how a component content management system with structured authoring (like the Paligo CCMS) can help.

The medical device industry is highly regulated. Depending on where a manufacturer sells its products, it may have to comply with regulations from more than one regulatory body. For example, for any device sold in the US, manufacturers must comply with regulations from the FDA (Food and Drug Administration). If they also want to sell their device in the EU, they must follow the European Union Medical Device Regulations (EU MDR). In addition, many countries also have their own regulations. And keep in mind that the more risk a medical device has, the more regulations it must follow. It can get pretty complicated.

Part of the compliance requirements involve the creation of comprehensive product documentation. Typically, medical devices require clear and accurate instructions on how they work and how to use them. This can include instructions for use, labeling on the device, instruction manuals, or user guides. This content supports users, outlining what needs to be done, how it should be done, and when it should be completed. Setup, operation, cleaning and maintenance, alarm and error-message troubleshooting, device specifications, and so on all need to be included. This information must be consistent across all documentation.

Other product documentation, such as advertising and promotional materials, are also subject to regulations, as mislabeling a medical device is a safety issue.

So, what is a ccms and how can CCMS software with structured authoring help?

You can create many types of documentation in a CCMS. That documentation may need to be published in different formats, in different locations, or have variations depending on the country or regulatory body.

First of all, CCMS software uses structured authoring, which means that you can create documents in a more organized and structured way. With a structured authoring model, you can create documents with a clear structure and hierarchy, making it easier to find and use the information you need, especially since all content is contained in a single source.

Single-sourcing enables you to create all your documentation in one place and publish it to multiple outputs. For example, many countries, notably in Europe, require you to deliver printed manuals with your devices. Other countries only require digital documentation, and some require both. By single-sourcing your documentation, you can meet all requirements without creating multiple versions of your documentation. The Paligo CCMS supports publishing to HTML5, PDF, CRMs, SCORM, and more.

Also, single-sourcing supports the ability to reuse content created for one type of documentation in another. The most straightforward example is a basic product description that is used in all product documentation, but there are plenty of other examples of content reuse, including instructions, warnings, and visual diagrams.

When you create content using a structured authoring model, you break the structured content into discrete topics that you can reuse in other publications. If you need to change the information – maybe you add a new feature or instruction – you make the change once, and it’s reflected everywhere that information is reused. Updates like this also happen due to changes in standards or regulations. By reusing content, you can make changes swiftly and ensure compliance.

All medical documentation must follow Good Documentation Practices (GDocP). These are guidelines for all forms, records, notes, and other documents produced and documented to meet GMP and other regulatory requirements. Using a CCMS that offers single-sourcing and content reuse, it’s much easier to ensure these guidelines are followed.

Warnings and cautions are critical elements of medical device documentation. The FDA, Health Canada, and the EU MDR all offer guidance on creating these warnings. CCMS software provides the ability to create and manage this type of information in a way that is consistent across all your content.

For example, warnings should be clear, concise, and easily visible within the product documentation, including user manuals, labels, and packaging. You should also use internationally recognized symbols, such as those defined by ISO 15223-1, to enhance comprehension, especially for global markets. Common symbols include those for “Warning,” “Caution,” “Do Not Reuse,” and “Do Not Dispose of in Household Waste.” You can configure the CCMS to use these symbols.

Another key consideration for using CCMS software to author and manage medical device documentation is support for non-text based content. User guides, manuals, and instructions often include illustrations, screenshots, and photos. When you manage this type of structured content in a CCMS, you add them as components, so the same version is reused across all technical documentation. This content reuse makes it much easier to deal with updates because you only have to update the image once, and it’s updated everywhere it’s used.

Another key benefit is versioning in a CCMS. Medical device documentation is updated regularly, either because a change was made to a device, how it works, how it’s used, or there’s a change to the standards or regulations the device adheres to. Versioning enables medical product writers, quality assurance and compliance teams, and others to track the changes made in the documentation software over time. A CCMS also provides a review and approval workflow so that any changes go through a review process before publication.

A medical device manufacturer rarely handles all the work involved in designing, developing, and manufacturing a device. More often, there are outside partners who provide parts, contribute to the manufacturing or design process, or help with marketing and selling devices globally.

With multiple partners involved, there needs to be a way to collaborate on documentation, and a CCMS supports that by enabling review and approval processes to include external players. In the CCMS, you can allow partners to review your product documentation and comment on it, ensuring that it’s accurate and up to date.

You can also manage translations in the CCMS using an internal translation team or by integrating with a third-party translation partner. Translating documentation in the CCMS is more cost-effective because you only need to translate the content once. All translations are applied everywhere the content is used.

Too often, documentation like user guides and instructions are an afterthought, left to the end of the manufacturing process. But it’s a critical element of any medical device. Safety and performance relate not only to the device, but to the labeling and instructional materials that go with it. The best component content management system will enable you to author, manage, and publish technical documentation in a way that is efficient and ensures its accuracy, completeness, and compliance is essential. That tool is a component content management system.

If you would like to learn more about how a CCMS can help with life science documentation, read here or schedule a demo.