Writing Regulatory Compliant Medical Device Manuals-Part 1

Before a medical device can be legally marketed in most countries it must be approved by a regulatory body. In the US, marketing approval is granted by the FDA. According to the FDA, Medical devices are classified into Class I, II, and III. Regulatory control increases from Class I to Class III. The device classification regulation defines the regulatory requirements for a general device type. Most Class I devices are exempt from Premarket Notification 510(k); most Class II devices require Premarket Notification 510(k); and most Class III devices require Premarket Approval. In the majority of cases devices are submitted via the 510(k) route.

In Europe the device must receive a CE mark before it can be marketed. The CE mark is granted by a Notified Body which grants its approval based on documents submitted and an inspection visit. As with the FDA process, devices are classified into different categories based mainly on the potential danger that they may pose to patients.

If you’d like a deeper explanation of regulatory processes there are several excellent sites on the web that describe both the European and American regulatory systems.

As a freelance technical writer you may be called upon to write a User Manual or Instructions for Use (IFU) for a medical device. As most of you are aware, there is regulatory aspect to the writing of a medical device manual. The manual must be filed together with many other documents to receive marketing approval in the US, Europe and many other countries. This series of posts will help you to work with regulatory experts in producing a regulatory-compliant manual and keeping it in compliance.

I’d like to stress that, as I wrote in the previous paragraph, the person who is ultimately responsible for ensuring that the manual is written correctly from a regulatory standpoint is the either the regulatory consultant hired by the company or the company’s in-house Regulatory Affairs Director.

The following posts will get into more specific details about how to write a regulatory compliant manual..


The Art of the Headline: “Voodoo sex ceremony starts fatal fire, officials say” – CNN.com”

If the headline above won’t get you to read the story then you have a serious problem. In one short sentence it combines sex, religion, death and fire. What more can you ask for?
Let’s face it we all hope that someone will read, with interest, what we have wrote. Even if the audience is one person for say, regulatory documents or you’re going for a larger audience with marcom material, you don’t want to feel that you are completely wasting your time.
Headlines (or headings) should serve two purposes; convey what information is in the section and make the reader feel that it might interest them. Keep in mind however that the headline style must be appropriate to who the audience is. There are headlines that are appropriate for the New York Post and headlines for the New England Journal of Medicine.

Marketing Yourself As a Freelance Writer

Let’s face it if most of us freelancers really enjoyed marketing we’d be in Marketing not it in writing. Makes sense, no? But if we want to feed ourselves and our families we have to constantly be on the lookout for new clients. And here let me add that those of you who think that you are all set because you have one big client who keeps you busy all the time, may be in for a rude awakening. I would prefer to be making a little less money with several clients than more money with one big client. A freelance relationship by its very nature means that your big client can drop you tomorrow with no prior notice suddenly drying up your income and we all know that little Suzie isn’t interested in hearing that she has to stop her ballet lessons because Daddy’s (or Mommy’s) big client pulled the plug. The time between when you start to look for a new client and when actual money enters your bank account from this new client can be several months.
The only way to overcome our aversion to marketing is to set aside several hours per week for marketing and not compromising on this point.
What do I mean by marketing? I don’t mean cold-calling. I do mean setting up a web site if you don’t already have one, or maintaining one that you already have. If you are a writer it is a minimum that you have a web site. There is no excuse for not having one. I also mean doing web searches for likely clients or outsourcing companies and contacting them. I also mean considering setting up a professional blog, working on your CV, registering with LinkdIn and putting an ad in Google AdWords or similar services. If some of these things cost money, so be it. The amount of money that you can make from one serious client will pay all your marketing costs for several years.
Finally, if you’re looking for just one book to teach you about sales I recommend Soft Selling in a Hard World by Jerry Vaas. It deals with the types of clients who would be buying our services and also has lots of concrete examples.

Two Ways to Build Up Your Portfolio Without Feeling Exploited

As I discussed in a previous post to find work as a freelancer you need to have a portfolio. To have a portfolio you need to work. Kind of a problem. I gave several suggestions for building up your portfolio without having to work for internet companies that pay poorly and probably won’t contribute much useful material to your portfolio anyway. Here are two more:
Go to a site where you can download freeware or shareware (there are lots of them) and find a program that looks interesting. Check to see if they have any documentation. It is usually very weak or non-existent. Contact the developers and volunteer to document the product. I doubt if they will say no. You will then have a complete manual (or helpfile) for your portfolio. Believe me no one interviewing you for a job will ask you if you were paid to write the manual, and it doesn’t really matter.
The second option is site called www.ifixit.com. Here you can help your fellowman by documenting a repair procedure and posting it. See the site for details.

Napping–Another Advantage To Working at Home

Why Companies Should Insist that Employees Take Naps – Tony Schwartz

2:08 PM Monday September 20, 2010 | Comments (75)

Good luck, right?

But here’s the reality: naps are a powerful source of competitive advantage. The recent evidence is overwhelming: naps are not just physically restorative, but also improve perceptual skills, motor skills, reaction time and alertness.

I experienced the power of naps myself when I was writing my new book, The Way We’re Working Isn’t Working.

I wrote at home, in the mornings, in three separate, highly focused 90 minute sessions. By the time I finished the last one, I was usually exhausted — physically, mentally and emotionally. I ate lunch and then took a 20 to 30 minute nap on a Barcalounger chair, which I bought just for that purpose.

When I awoke, I felt incredibly rejuvenated. Where I might otherwise have dragged myself through the afternoon, I was able to focus effectively on work other than writing until 7 pm or so, without feeling fatigued.

via Why Companies Should Insist that Employees Take Naps – Tony Schwartz – Harvard Business Review.

There you have it. Who can argue with the Harvard Business School? What’s next? drinking beer and lying on the couch for 1/2 the day also boosts productivity?

I have a couch in my home office and I usually nap every day for about 1/2 hour. Any more than that and I feel kind of dopey when I wake up. I definitely feel refreshed and am able to work longer following a nap.
Those of us who have dogs or cats know that they spend probably 20 hours a day sleeping and look how productive they are. Wait maybe that’s not such a good example.

Is This You? – People Who Work From Home Are Targets for Favors – WSJ.com

I recently came across this article:
People Who Work From Home Are Targets for Favors – WSJ.com.

Is this you?
Do you sometimes feel that people think that because you are at home that means that you aren’t working and are available for their missions?
How do I get around this problem? First of all I have no problem saying “no” if it really doesn’t fit into my plans. After all would I call somebody up at their place of work and ask them to run out and do me a favor? On the other hand I think that it is important to exploit the advantages of working from home and setting your own hours. One of these advantages is that you can help out friends family and community.
Second, if people ask me about my work I explain to them that my work involves a certain amount of traveling, so I’m not always at home and therefore not always available for missions.

Review of hideipvpn.com to Hide Your IP Address

Those of us living outside the US and Europe are sometimes blocked from accessing sites that we may want to access. One way to get around this and also to ensure anonymity when browsing is through the use of IP blocking software. I was recently provided with temporary use of hideipvpn to write a review. Here it is:

How hard is it to set up?
It was very straightforward to set up. Speaking as a technical communicator the instructions were clear and easy to follow.

Is it hard to connect and disconnect?
Not at all. You connect and disconnect as you would for any other internet connection.

Is it legal?
Although I am not a lawyer from what I understand it is legal. There is no law stating that you have to show your IP, it is like blocking your phone number from caller ID

Does it work?
Yes it certainly does. I confirmed this by first of all going to a site that you can use to look up IPs and it showed my IP as being in LA California USA, I then went into Google News and in the local news section instead of Israel it gave me news from Seattle. Finally I signed into a site whose access is blocked to IPs outside the USA and I was able to enter.

Third, does it slow your browsing?
Yes it does. I went to a site that checks your browsing speed and checked with the hidden IP and with my normal IP. The download speed of the hidden was slightly half that of my normal IP. The upload speed of the hidden IP was slightly slower. I repeated the test three times and got similar results each time.To be honest in normal browsing and streaming I didn’t notice any difference.

For additional details about the product see http://www.hideipvpn.com.