This is a blog written by Elemed expert guest blogger Elly Gysels. Want to be a guest blogger? Email karen@elemed.eu for more info!
Imagine you are a reviewer at a regulatory authority (e.g., FDA in the US, ANVISA in Brazil) or a conformity assessment body. You are on a very busy schedule and need to work through huge files for many different products from different manufacturers – dozens of them, year in, year out. You have a lot of work ahead of you and want to progress with the review of your current application, yet after half an hour clicking and searching through files you haven’t found the piece of information you are looking for
If you work at a company seeking approval for a new medical device, you (as well as your management) would like to get as smoothly and quickly as possible through the approval process so patients have access to your device. Given that approvals of medical devices are based on their documentation, you would like to make it as easy as possible for the regulatory reviewer to work through your application.
Thomas Hood once mentioned, “easy reading is damned hard writing”. Here are some points to consider when writing documents that are part of your regulatory submission file.
Before you get started
- For whom are you writing the document? Identify your audience and what they are looking for, what they pay attention to. Put yourself in their shoes. Keep in mind your readers may have a variety of educational backgrounds and may not be native speakers.
- Why are you writing the document? What is the message you would like to convey? Be clear on the goal of the document.
- By when do you need to have the document ready? Plan time not only for writing the document, but also for the internal review and for implementing reviewer comments. Identify your reviewers early and let them know when they will receive the document for review, how long you think it will take them and by when you need their feedback. This allows them to schedule time in their calendar and make sure you can adhere to your timelines.
- Are there any guidance documents you could or should follow? Familiarize yourself with guidance documents available for the type of document you are writing.
When writing
- Include an executive summary in your document. This sets the scene and allows the reviewer to orient themselves.
- Structure your document logically. What story does the table of content tell the reader?
- Consider the flow of your document, including flow between and within sections and paragraphs. Don’t surprise your reader with an unexpected twist or by jumping back and forth.
- Use bullet points to list items, to convey the relation between statements and to make your text «lighter».
- Keep your sentences short. Short sentences are usually easier to read and may help non-native speakers better understand the text. Also, translations of the document will be less error-prone if sentences are short.
- Use words your reader is familiar with. This may be, e.g.: terminology suggested by the international medical device regulators forum; terms used in regulations, standards and scientific literature in the field (both technical and medical). You may want to set up a glossary to ensure consistency in use of terms and abbreviations between documents.
- Make sure tables, figures and referenced documents are cited in the text, and that the text does not cite non-existing tables, figures and references.
- Make it visual. Use consistent formatting. Include graphs, pictures, renderings and flowcharts.
- Use grammar and spell checks if these are available. Punctuation rules, for instance, differ between languages and these checks may be very helpful in getting it right. However, do not use them blindly; they will not bring all (kinds of) errors to your attention.
When you (think you) are done
Getting a fresh pair of eyes to look over the document can only improve it. Seek feedback. Does the document read well? Is the message clear? Do the statements make sense? Has anything been forgotten? Get someone to double check numbers against source data. Include specific questions for your reviewers if you have any.
Also consider the document in the context of the documentation it is part of. Is it aligned with other documents? Do the documents tell the same story? Is it clear for the reviewer which information can be found where?
Questions
First of all, prevention is better than cure. It will save you a lot of time and money (and frustration). Therefore, you would want to ensure there are no contradictions between documents and that the writing is not ambiguous, that the information provided is complete and clear. Anticipate potential questions and address them in your file.
If the regulatory reviewers come back with questions, make sure you provide them with the information they are looking for. Do not just write about the right subject, make sure the question is adequately addressed. If it is not immediately clear what the concern behind the question is, encourage a multidisciplinary discussion, e.g., between regulatory, subject matter experts and product owners to bring in different perspectives, interpretations and points to cover. Make sure the answer addresses all of these concisely, clearly and pointedly and provide reference documents as appropriate.
Even if the reviewer likes reading good books with creative metaphors, beyond-wild imagination, poetic language and some laugh-to-tears passages, this is not what they will be looking for in your regulatory submission file. Make your file easy to understand and to locate information in. Make your documents easy to read and digest. This will allow your reviewer to read that good book in their free time.
About the author
Elly Gysels
HEAD OF REGULATORY AFFAIRS AT SENSILE MEDICAL
Elly has been working in medical devices regulatory affairs for five years and currently heads the regulatory affairs team at Sensile Medical, a Gerresheimer company. Prior to that she worked more than 4 years in medical scientific communication, in both the medtech and pharma industry. She has 15 years’ experience in the medical device industry in multiple therapeutic areas. She is a multilingual scientific professional with an engineering physics degree (Ghent University, Belgium) and a PhD in signal processing for Brain-Computer Interfaces (EPFL, Switzerland).
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