Criterion Edge
Experienced in pharmaceutical, biologic, medical device regulatory writing, the Criterion Edge team of specialized medical writers provides our clients with the flexibility needed to meet your critical writing deliverables. Our team specializes in the development and writing of Clinical Evaluation Reports for Class I, II, and III Medical Devices. With over four decades of direct industry experience, Criterion Edge is at the intersection of skill and scalability in Regulatory Writing Services. Already have an internal team? We can support your team in any capacity. Criterion Edge also provides services for Medical Safety Support.
For questions about our services and support options, email: [email protected]
For careers, email: [email protected]
Maximizing the Value of Literature Reviews in Pharma,From Competitive Intelligence to Market Success
Leveraging AI in Regulatory Writing — Opportunities & What Medical Device Leaders Should Know
Maximizing the Value of Literature Reviews for IVD, From Competitive Intelligence to Market Success
Maximizing the Value of Literature Reviews for Medical Devices
Medical Device: Strategies to Support a Successful Technical Documentation Assessment (TDA)
Overcoming Deadline Bottlenecks in Pharma: How a Writing Team Can Help
Devices in Focus: How to Save Time & Money with Real World Evidence
Ask the Expert: The Role of Real-World Evidence (RWE) in Regulatory Submissions
Emerging Trends in Global Regulations: Insights Into More Efficient Regulatory Writing Practices
Pharma In Focus: The Role of Real-World Evidence (RWE) in Regulatory Submissions
Trending Topics: From the AI Act to Orphan Devices, Key Takeaways from RAPS EU Convergence 2024
Considerations for Companion Diagnostics: Lessons Learned and Key Takeaways from DIA 2024
Understanding FDA: Essentials for Briefing Books in Pre-IND, Pre-NDA, and Pre-BLA Meetings
IVDR in Focus: Tips for Performance Evaluation Planning to Support Your Transition from IVDD to IVDR
Practical Strategies to Successfully Navigate Key IVDR Regulations Applicable to SaMD Devices
How Much Data is “Sufficient”? Navigating Clinical Evidence Requirements Under the MDR and IVDR
Ask The Expert: IVDR - Early Experience and Feedback
Pro Tips Unveiled: Expert Systematic Literature Review Strategies for EU IVDR Submissions
It's All Interconnected - Hidden Traps That Can Derail Your PER
IVDR Readiness: Creating a Blueprint to Build a Strong PER
Ask the Expert: Plain Language Content - Effective Communication for Patients, Caregivers, and HCPs
Integration of Plain Language Content and Infographics: Strategies to Enhance HCP Engagement
Developing Effective Patient-Focused Content: Writing Plain Language Lay Summaries and SSCPs
Critical Concepts Medical Device Software: Risk Class, Qualification, & Safety/Performance Outcomes
Stay Focused: The Purpose of the SVR and Tips for Building a Strong PER Foundation
Ask the Expert: Requirements & Challenges of Plain Language Content Creation for Multiple Audiences
Plain Language Communication in Healthcare - Part 1: Understanding Requirements and Challenges
New Requirements for In Vitro Diagnostics: Lessons Learned from the AAMI/FDA/BSI Annual Conference
ATE: 2023 MDR/IVDR Submission Readiness: Getting Your Ducks in a Row from the Writer’s Perspective