RE: Technical Writing in the Medical Device Industry

Subject: RE: Technical Writing in the Medical Device Industry
From: Dan Goldstein <DGoldstein -at- nuot -dot- com>
To: "TECHWR-L (techwr-l -at- lists -dot- techwr-l -dot- com)" <techwr-l -at- lists -dot- techwr-l -dot- com>
Date: Thu, 18 Feb 2016 16:19:53 +0000

Hi Naomi,

Best gig in the world. I've been in medical devices since 2002, and I love it.

The kind of tech writing you're doing in medical devices is called Regulatory Affairs and Quality Assurance. Your job title should reflect that specialization at some point (QA Manager, etc.).

I'm guessing that the "retracted manual" that you're using might be "HHS Publication FDA 97-4179, Medical Device Quality Systems Manual: A Small Entity Compliance Guide." If so, great! It's not the best-written guide in the world, but everything in it is still accurate.

Writing a new quality system is a terrific adventure. There are a thousand consultants who will be happy to charge by the hour, and they are almost guaranteed to swell your quality system to a far greater size than you need. The key is to keep everything as concise and direct as possible; successive inspectors and auditors will add details in any case.

Writing a 510(k) is a whole other kettle of fish, and you'll need guidance. For this, you *might* need a consultant, but I'd start with FDA's own staff, since you're already paying them in taxes. You should be able to get a meeting with the relevant department *before* you draft the 510(k), so you know what they'll be looking for (and to guarantee that no one asks later on for a PMA (aaargh!) instead. I also highly recommend FDA's Division of Small Manufacturers, International and Consumer Assistance (DSMICA), whom you can contact at They haven't steered me wrong yet.

As far as books go, anything published by AAMI ( should be worth a read. If your company can spring for seminars, go to AAMI and nobody else. Recommended seminars for beginners:

* Quality System Requirements and Industry Practice
* Design Control Requirements and Industry Practice
... and if your device includes software:
* Developing and Validating Software for the Medical Device Industry

Membership in AAMI is usually worth the discount even if you go to only one seminar per year.

Some pitfalls to watch out for from Day One: Part 11 for electronic signatures and recordkeeping; verification vs. validation; and the difference between validating device software and quality system software.

Later pitfalls: complaints, CAPAs, supplier controls, and employee training. But really, it's all one big funhouse.

Good luck!


-----Original Message-----
From: Naomi L Burnett
Sent: Thursday, February 18, 2016 8:49 AM
To: techwr-l -at- lists -dot- techwr-l -dot- com
Subject: Technical Writing in the Medical Device Industry

Hi everyone,

Do you have any suggestions of books, blogs, or other resources that would help a beginning tech writer in the medical device industry?

To give you a little background (if it will help), I began a job as a tech writer in the medical device industry a few months ago at a very small company. I'm new to everything about this job; I have my Master's Degree in English Literature, and this is my first tech writing experience.

So far, on the job, I've written a draft of the quality manual (using general Internet research, a retracted FDA manual on quality systems that my boss saved, and of course 21 C.F.R. part 820). I'm now working on the standard operating procedures for the quality system and researching how to write a 510(k) for a new product.

I would love any advice you experienced tech writers might have about tech writing in the medical device industry, and I would especially appreciate any titles of (or links to) research resources that might be of help for my research.

Thank you so much!


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Technical Writing in the Medical Device Industry: From: Naomi L Burnett

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