Writing in a Regulated Environment – Medical Device Instructions for Use (IFU)

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Opportunities for technical writing abound across the regulatory landscape, and writing medical device instructions for use (IFUs) is one such opportunity.  Finding and staying on this path, however, is not for every technical writer. Writing IFUs is a unique technical writing niche.

With many years of experience documenting software, an undergraduate degree in Biology, and a love for science writing, I started writing user manuals for laboratory instrumentation in the 2000s. After the recession, wishing for some corporate stability, I accepted an offer to write IFUs at a medical device company. Based on this experience, I’ve uncovered three important considerations when approaching IFU assignments.

Content ownership and collaboration

If you are accustomed to doing your own research, and finding your own answers as you create your material, you will find very quickly that you are not the “owner” of your content. Cross-functional collaboration has always been important in technical writing, but it is essential in a regulated environment. You must coordinate closely with your Regulatory, Marketing, Legal, Compliance, and Quality Engineering colleagues and understand the regulatory requirements of their jobs in order to do yours effectively.

These collaborators will have specific ideas about how information must be written to comply with regulations and meet marketing objectives. Settling on communications that meet everyone’s requirements has always been part of your job as a technical writer. But in regulated environments, the tension is magnified by the fact that the notified bodies (organizations that certify your material under the various regulations) are among your primary audiences. You may have a lot of discussions about “shall” or “will” and use of the passive voice. It may take an hour meeting or more to come to a consensus on final text.

Compliance

Unlike some kinds of technical writing, content for IFUs includes an additional challenge – how to interpret the regulations you are working to comply with. This can sometimes be a moving target. Think you have nailed down the symbol that should go at the end of your document? Well, ISO uses this symbol, and FDA requires a different one. And, add in the EU guidelines, which are essentially harmonized with FDA, but not entirely. And, the symbol regulations may be changing next year! The rest of the world (Asia, Canada, Brazil etc.) may have different requirements.

You will spend a lot of your time identifying how your content will comply with more than a handful of regulations with a global scope. Be prepared to acknowledge that the “facts” may just be the best interpretation of the regulation as a consensus of all of your Regulatory colleagues. Working out the intricacies of multiple regulatory requirements can be fun, but to be successful, you must be able tolerate a delayed answer and ambiguity under tight deadlines.

Administrative work

Unless your company has a dedicated administrative assistant, you may be spending approximately 50% or more of your time processing change orders for your documents. All technical documents must be controlled in a Product Life Management (PLM) systems under strict quality policies. You will need to navigate the PLM system your company has selected for document control. If you like checking boxes, and feeling like you have accomplished things by doing administrative tasks, this can be the easiest part of the gig. If you are concept person like me and prefer working with ideas, you will be longing to get back to the real work of crafting sentences to communicate technical concepts.

What to do if you interested in writing IFUs

If you are interested in medical device instructions for use, identify the kinds of regulations that govern your selected industry, and the products you are interested in writing about. A good way to start is to familiarize yourself with FDA and EU rules for labeling (the regulatory term for all customer-facing documentation describing the product). The following links provide a good introduction. Then, when you land that IFU role you never knew you’d dreamed of, you can with your colleagues to develop the best instructions you can for your selected industry and audience.

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