Regulatory Writing/Consultation-A Career Upgrade for Technical Communicators–Part 1

I have been active in the technical writing field for more than 20 years and I have met more than a few writers who feel blocked in their career path both in terms of interest and money. One alternative that uses many of the same skill sets used in technical communication is the regulatory field.

My personal story is a good illustration of this. I was working a freelance technical writer for a start-up company that was developing a new type of imaging device to be used in the operating room. The device was quite large and complicated and required (to my delight)  a several hundred page manual. In addition, for the company to survive it needed to receive regulatory approval from the FDA to market its device. Due to the novel approach of this device the approval was far from automatic. Because it was kind of difficult to get clear explanations about the system from many of the engineers (sound familiar?) I began asking the VP of regulatory affairs. He was not a native English speaker and he then asked me to  go over some documents that he wrote to check the English. I asked him what each document was for and he provided me with good explanations of various aspects of the regulatory process and I spent more and more time helping him with the FDA submission. The company got the FDA approval, began marketing it device in the US and was eventually bought out by the multinational medical device company Medtronic. I leveraged my knowledge of preparation of regulatory documents to find more gigs and soon had enough experience to be able to honestly present myself as a regulatory consultant. I established my own company Carmel Scientific where I offer regulatory consulting and medical and technical writing services. The VP regulatory affairs left the company to set up his own consulting firm and I have been working with him as a subcontractor for the past 17 years.

In my next entry I’ll compare the two fields and offer advice on how to make the switch.


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..