We are excited to announce the upcoming third edition of our book, Global Medical Device Regulatory Strategy. We are in need of additional subject matter experts to fill author gaps. Currently, we are looking for volunteer contributors to review and update chapters titled:
- Driving Successful Commercial Product Launches
- Core Development Teams
- Risk Management Strategies for Device Design and Development Processes
- Global Medical Device Labeling Strategies
Responsibilities
- Accepted candidates will have six weeks to update content and adapt to style guidelines.
- Chapters needed listed below
- One volunteer needed per chapter
Chapter 1: Driving Successful Commercial Product Launches
The chapter focuses on value-based healthcare, requiring medical device manufacturers to show improved patient outcomes, cost-effectiveness, and efficiency. It highlights the importance of cross-functional collaboration and market access throughout the product development process. An author updating this content should be familiar with healthcare market access strategies, reimbursement frameworks, and global commercialization processes for medical devices.
Chapter 3: Core Development Teams
This chapter focuses on how CDTs move a product from concept to commercialization while balancing regulatory compliance, quality systems, and business objectives. An author updating this content requires knowledge of medical device product development, QMS, design controls, global commercialization, and cross-functional team management.
Chapter 6: Risk Management Strategies for Device Design and Development Processes
This chapter focuses on the need for a total product lifecycle approach to risk management frameworks and regulatory expectations. An author updating this chapter requires expertise in medical device regulation, quality systems, global product strategy, human factors engineering, enterprise-level risk governance, and global challenges in medical device development.
Chapter 7: Global Medical Device Labeling Strategies
The chapter focuses on labeling as both a compliance requirement and a patient safety tool. It highlights how errors can lead to recalls, injuries, or liability. An author updating this chapter requires expertise in EU and U.S. device regulations, ISO standards for labeling and symbols, global harmonization practices, and human factors in labeling design.
Qualifications
- RAC not required
- RAPS Membership not required but encouraged
- Strong understanding of Medical Device Strategy
Experience
Volunteer Details
- One author needed per chapter
- Sign-up required by October 24, 2025
- Earn five credits towards RAC Recertification
- Receive a complimentary eBook of the publication.
How to Apply
If you are interested in contributing as an author, please email Annissa Noblejas (anoblejas@raps.org) and include your resume/CV. We would love to hear about your experience and expertise in the field.