Woman working medical device regulations

You've already read a few benefits in the title but let's reiterate:

  • Earn RAC points
  • Enhance your resume/LinkedIn profile
  • Get published, and share your expertise with industry peers in the process

These are just three of the several reasons you should consider writing an article for RAPS' Regulatory Focus.

Don't sweat it if writing isn't your forte - there's nothing to be afraid of. The editorial board is there to you help you bring your ideas to life (and correct all those grammatical and punctuation errors). And once you get started, the entire writing process usually takes less time than you think. RAPS is looking for authors for the September and October 2016 issues of Regulatory FocusOr... maybe you have an idea for an article that could appear in any issue? Either way, now is your chance and here are more specific details.


The theme for September is “Advertising, Promotion and Digital/Social Media.” This issue will explore the latest trends in advertising and promotion of medical devices and prescription drugs, including the challenges of social media and digital marketing aimed at healthcare professionals and consumers. Article topics will include:

  • Latest trends in FDA and government enforcement
  • How to set up internal systems to support branded social media campaigns
  • The First Amendment and product promotion
  • When press releases become promotional
  • Identifying considerations when promoting medical devices


The theme for October is “Strategies for Working with Global Regulatory Agencies.” This issue will explore strategies for managing the interface between regulatory and quality, including the practical application of working with global regulatory agencies, other regulatory pathways and new trends, such as quality metrics, regulatory publishing and submissions and considerations for combination drug/devices. Articles or case studies could focus on any of the following topics:

  • Integration with management
  • Unique strategies
  • Solutions for electronic submissions
  • Considerations for budgeting for a regulatory submission
  • Consideration of an outsourcing option for parts or all of a submission
  • Revolutionary trends for shortening the timeline
  • Planning for the multi-year regulatory process
  • Pros/cons of breakthrough and other novel submission strategies vs. other types of submissions

Nothing above hitting your sweet spot? An article that could appear in any issue might be about education and professional development, regulatory bodies, quality and compliance, or regulatory science and leading edge technology. That covers a lot, doesn't it?

To volunteer as an author, email editor@raps.org.

For more information on professional development opportunities likes this one, subscribe to our blog below.

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