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Three Things Every Medical Technical Writer Learns the Hard Way

What a thrill it is to land a job in the medical device industry as a Medical Technical Writer until you run into the mine-field of regulated documentation. Medical devices in the U.S. are regulated by the U.S. Food and Drug Administration (FDA). Between the demands of the FDA and complying with the requirements of the International Organization for Standardization (ISO), the myriad of rules and regulations that medical device manufacturers have to follow is mind-boggling. Ultimately, medical device manufacturers have developed extensive processes to ensure adherence to the regulations.
 

medical technical writer

So, let’s really up the ante by having that regulated documentation translated into, say, 20 languages, and now you have a recipe for disaster for a new employee. It doesn't matter how many companies you may have worked for, you can count on the fact that the one that just hired you has their own interpretation of the rules and regulations, and the processes they use to adhere to them.

 

After years as a Medical Technical Writer, here are three conventions I learned the hard way:

Updates

Never change a word in an approved document that was not requested.

Why? Because every word that is changed has to be approved. Any changes that were not requested will have to be defended to the Approvers. And don’t think you can sneak in those changes and no one will know. A previously translated document means that the translators have Translation Memory file, when your updated version is compared to their Translation Memory files, you’ll be busted. At approximately $5 a translated word, “I thought it sounded better that way” isn’t going to fly! Bottom line, you can’t change a word that isn’t requested just because you thought it was a good idea.

Placeholders

Find out about placeholder text before it becomes a problem.

Every company has their own version of placeholder text that is intended to be filled in later with the actual data before publication. It could be dates or names or other data that isn’t available at the time of the writing. The convention could be entering XXXXs or text in brackets or parenthesis. If you don’t know that, you won’t know to substitute the actual data before publication, which can lead to having a document recalled or being designated as non-conforming. Always ask if a company uses placeholder text and if yes, what are the rules and how will you recognize it? Do your homework on placeholder text before it becomes a problem.

Approvals

Check that all documents and forms associated with an approval process are correct before you hit the Send button.

Where there are regulations, there are documents that have to be approved to ensure they comply with the regulations. Approvers are usually delegated by each department that is responsible to weigh in on the content. Approvers are required to review the content and ensure that it complies with the regulatory standards that are mandated in their department. There is no greater minefield in the day of a Medical Technical Writer than the approval process. Not only do you have to produce an error-free copy of the document for review, you must also ensure that any approval forms that accompany the document are properly filled out. Therein lays the danger. Approval forms are chock-full of vital information that is the bastion of the well informed. To this day, I have a mild anxiety attack right before I hit the Send button on a Request for Approval. Never fill one out in a hurry. Never send one at the last minute before a meeting. Check that the document is the correct version, being sent to the correct approvers, for the correct product line, and that every piece of data on the requesting form is absolutely associated with that approval. Check and recheck before you send a document for approval.  Check twice, send once.

The Take Aways

  1. Never change a word in an approved document that was not requested.

  2. Find and update placeholder text before it becomes a problem.

  3. Check that all documents and forms associated with the approval process are correct.

 

What are some of the medical industry conventions you've learned? Share your comment below.

Topics: technical writing

 EU MDR