May 3, 2018

Benefits of Outsourced Medical Writing

As business increases, medical device and pharmaceutical companies are finding success turning to outside vendors to meet their technical and regulatory writing needs. In doing so, these organizations gain real and specific benefits that, because of a streamlined approach, can lead to a bigger bottom line. Below are a few examples of the advantages that your company can gain by outsourcing your writing needs.



Save Money

Of course money is top of mind when it comes to benefits. No matter how great other benefits might be, if it doesn’t make sense fiscally, why do it? Organizations can save money several ways when outsourcing. The first is by reducing or outright eliminating in-house staff and turning to a team of experienced writers from the outside, an organization saves on costs associated with in-house employees. This includes, standard salaries, paid time off, and insurance costs.


The next way that outsourced writing can save money is through bundling services. Like in any line of work, technical writers can offer a package of services for less money. Once again, by saving money in this area, your company will be able to allocate more funds where needed.


A focus on writingFocus on Writing

It can often times be difficult for organizations, especially smaller ones, to divert their attention away from research and development to focus on other aspects of the company. Again, this comes down to how resources within a company’s structure are allocated. By outsourcing writing duties to a team of experts, a company knows that all aspects of the technical writing process will be covered.

The medical device and pharmaceutical landscape is constantly evolving. By employing a team of experts to handle the writing needs, you can have the piece of mind, knowing that all rules and regulations will be followed with precision.



As stated above, often times keeping a staff of in-house writers can, at times, be a bit of an albatross for a company. Utilizing outsourced writing professionals can free up an organization, as you only employee their services when needed.

As most companies can attest, their writing needs fluctuate throughout the year, depending on where their products stand in the pipeline. By employing outside vendors based on need, an organization frees itself up to use the extra capital as they see fit.

In the end, because of the variables involved, every company’s technical writing needs will be different. However, regardless of the variables, organizations should always be looking for ways to employ the best individuals for their needs, find ways to become more flexible through resource allocation, and finally, save money. Outsourcing writing duties to a team of experts can help accomplish all of this.

Criterion Edge is a regulatory writing company that provides outsourced writing services to the pharmaceutical and medical device industries. The company’s expertise in regulatory writing best practices, honed over decades, produces superior deliverables and provides budget, resource and timeline flexibility for regulatory managers. Criterion Edge empowers companies to deliver superior health care solutions. To learn more about how Criterion Edge can help you achieve your regulatory goals, click here to contact us, call us at 805-202-5520, or use the email:

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December 12, 2017

3 Approaches to Increase Flexibility and Scalability in Your Regulatory Writing

Frustrated Businesswoman

What is trying your patience these days? Changing guidelines? Higher standards for methodological rigor? More frequent submissions? The bar for regulatory writing keeps rising with no end in sight. Add training requirements, unforeseen developments, and conflicting deadlines, and you will likely find your writing team struggling to keep up. (more…)

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May 12, 2017

How Outsourced Regulatory Writing Can Benefit Your Organization

Thinking about using an outsourced regulatory writing team, but aren’t sure of the advantages?

In today’s medical device and pharmaceutical environment, it’s imperative to analyze and present complex information clearly and concisely while meeting critical timelines. Partnering with team of experienced regulatory writers can be a beneficial alternative to maintaining an in-house writing staff. (more…)

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May 12, 2017

New MEDDEV Guidelines: What You Need to Know

In July 2016, revision 4 of the MEDDEV 2.7/1 guidelines was released to much anticipation within the medical device community. The document has been expanded and now contains expanded details on requirements that effect almost every aspect of the clinical evaluation of medical devices with CE-mark. So what do you need to know to make sure your organization is in compliance? (more…)

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