How to proofread medical writing: a practical guide for regulated teams

Errors in medical writing are not just editorial mistakes—they can lead to compliance issues, delayed approvals, and even patient safety risks.

From clinical documents and IFUs to regulatory submissions and training materials, medical writing must be precise, consistent, and aligned across multiple formats and versions.

That’s why proofreading in regulated environments goes far beyond spelling and grammar. It requires structured processes, version control, and the ability to detect even the smallest discrepancies.

This guide explains how to proofread medical writing effectively, and how regulated teams reduce risk while improving efficiency.

What is medical writing?

Medical writing refers to the creation of scientific, clinical, regulatory, and educational content used across the healthcare and life sciences industries.

It includes:

• Regulatory documents (e.g. clinical trial reports, submissions)
• Instructions for use (IFUs) and patient information leaflets
• Packaging and labeling content
• Educational and training materials
• Promotional and medical communications

Because this content directly impacts regulatory approval, product use, and patient safety, accuracy is critical at every stage.

Medical writing target groups

Medical writing has very many target groups in both regulatory and non-regulatory contexts. Some of the key ones are:

• Healthcare Providers
• Patients
• Regulatory bodies
• Hospitals and other healthcare providers
• Insurance (health or otherwise) stakeholders
• Educational and training institutions
• Internal corporate stakeholders (e.g. within different functions of a pharmaceutical company or medical device manufacturer)
• Visitors to medical- and health-focused websites, or public events
• Industry press

Delving deeper into the different types of medical writing, most professionals agree on several categories that cover the whole range:

Regulatory and clinical documentation

This spans the various types of medical writing documents in research and development, clinical testing, submission, approval, and in the post-approval regulatory environment. Labeling and packaging, and instructions for use are very high-profile examples of this type of medical writing. It includes a hybrid of paper-based and digital (online) labeling.

Medical proofreading can be a very onerous task in this category, as inaccuracies can have drastic consequences for patients, and result in costly litigation for medical device manufacturers.

Educational and training materials

Examples are training manuals, slides, posters and other visual aids for various audiences, particularly training for Healthcare Providers. Video and multimedia scripts are other types in this category.

Medical communications

This includes documents such as press releases, white papers, case studies, health articles, marketing brochures, manuscripts, slide decks and posters, general health publications and general health websites. Research articles, reviews and case reports of individual patients are other types.

A day in the life of a medical writer

Medical writing requires research, flexibility and often working to tough deadlines, especially in medical communications agencies, where multiple projects are the norm.

Joe Russo is a technical writer and information architect at Intuitive Surgical, best known for its da Vinci robotic surgical systems. He describes how a medical writing project might begin with a single 500-page document that he breaks down into single-page modules. These modules are topic-based and worked on by multiple medical writers simultaneously. This, he says, provides the agility the company needs in its process steps. He supports the medical writers with training, tools and output quality steps.

Typically, he will enter the process for producing product information at several points, initially by ensuring the medical writers have all medical device specifications for the document version. Finding synergies and overlaps is important. He looks at ways of re-using existing content from previous versions, as well as what information must be re-used across the different single-page modules. At the output stage, he supports medical writers through medical editing and updating style sheets for any changes that may have been made to a product after the medical writers have set to work. He also gives input on layout, tables and graphics.

Throughout the process, medical writers consult closely with the subject matter experts (SMEs). Product features, for instance, may change along the way. Typically, a project concludes with validation, verification and approval of the document modules. Tools used throughout these steps include standard software such as MS Office, but also Intuitive Surgical’s product lifecycle management system and TVT comparison software from Schlafender Hase® for proofreading and verifying documents. TVT makes the comparison of output incredibly easy, much simpler and much cleaner than other comparison tools, explains Joe Russo.

Tools and resources for medical writers

TVT, along with its modules TVT Artwork®, TVT Spelling® and TVT Barcode®, will compare any two document versions within seconds and highlight deviations in text, artwork and barcodes. Creating custom dictionaries is all possible in TVT, which is useful for the medical proofreading of terminology and corporate-specific nomenclature. It can be easily integrated into any information system, such as a product lifecycle management system. Annotation and report functions bring transparency to workflows.

In terms of online resources, in the American Medical Writers Association (AMWA) has a wealth of information, as does the European Medical Writers Association. Both are an excellent springboard for learning more about medical writing, medical proofreading and editing. Here, you can listen to Joe Russo, in full, talking about his job.

Would you like to find out more about how TVT comparison software can support you as a medical writer? Get in touch with us below.

References

1.https://info.amwa.org/ultimate-guide-to-becoming-a-medical-writer#what_is_medical_writing
See https://www.amwa.org for the American Medical Writers Association, and https://www.emwa.org for the European body.