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]
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Emerging Trends in Global Regulations: Insights Into More Efficient Regulatory Writing Practices
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Trending Topics: From the AI Act to Orphan Devices, Key Takeaways from RAPS EU Convergence 2024
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Considerations for Companion Diagnostics: Lessons Learned and Key Takeaways from DIA 2024
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Understanding FDA: Essentials for Briefing Books in Pre-IND, Pre-NDA, and Pre-BLA Meetings
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IVDR in Focus: Tips for Performance Evaluation Planning to Support Your Transition from IVDD to IVDR
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Practical Strategies to Successfully Navigate Key IVDR Regulations Applicable to SaMD Devices
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How Much Data is “Sufficient”? Navigating Clinical Evidence Requirements Under the MDR and IVDR
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Ask The Expert: IVDR - Early Experience and Feedback
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Pro Tips Unveiled: Expert Systematic Literature Review Strategies for EU IVDR Submissions
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It's All Interconnected - Hidden Traps That Can Derail Your PER
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IVDR Readiness: Creating a Blueprint to Build a Strong PER
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Ask the Expert: Plain Language Content - Effective Communication for Patients, Caregivers, and HCPs
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Integration of Plain Language Content and Infographics: Strategies to Enhance HCP Engagement
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Developing Effective Patient-Focused Content: Writing Plain Language Lay Summaries and SSCPs
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Critical Concepts Medical Device Software: Risk Class, Qualification, & Safety/Performance Ou...
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Ask the Expert: Requirements & Challenges of Plain Language Content Creation for Multiple Aud...
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Plain Language Communication in Healthcare - Part 1: Understanding Requirements and Challenges
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New Requirements for In Vitro Diagnostics: Lessons Learned from the AAMI/FDA/BSI Annual Conference
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ATE: 2023 MDR/IVDR Submission Readiness: Getting Your Ducks in a Row from the Writer’s Perspective
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Ask the Expert: A Deep Dive into MDR and IVDR Device Classification and Data Collection Strategies
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Critical Concepts: Deep Dive into MDR and IVDR Device Classification and Data Collection Strategies
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Critical Concepts: The Role of Post Market Surveillance in Establishing Data Sufficiency
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MedTech Digital Week: The Role of RA in the Clinical and Performance Evaluation Process
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