IVD DEVICE
Enhancing Market Success for IVD
Criterion Edge is a distinguished global provider in the MedTech industry, dedicated to advancing compliance and enhancing market success through expert regulatory, scientific, and clinical writing services.
Services Tailored to Your Needs
Our team of experienced writers and medical librarians specialize in creating high-quality, compliant documentation essential for regulatory submissions and scientific communications.
Regulatory and Clinical Writing
- Scientific Validity Reports (SVR)
- Clinical Performance Reports (CPR)
- Analytical Performance Reports (APR)
- Performance Evaluation Reports (PER)
- Regulatory Submissions (US, EU, UK)
- Regulatory Notified Body Responses
- Post-Market Surveillance Plans (PMS)
Systematic Literature Reviews
- Search & Screening
- PRISMA Flowcharts
- Evidence Weighting/Appraisals
- Literature Review Reports
- Data Extraction Tables & Analyses
- Surveillance of Published Literature
- Executive Summary of Findings
Scientific and Technical Documentation
- Companion Diagnostics Writing Support
- Performance Evaluation Documentation
- Risk Analysis & Management Documents
- Regulatory Document Gap Analyses
- Template Review & Development
- Acceptance & Performance Measures
- Summary of Safety & Performance (SSP)
THE EXPERTS YOU NEED, WHEN YOU NEED THEM
Expertise
Achieve high-quality, compliant written deliverables with our deep bench of seasoned regulatory writers and medical librarians that have specialized degrees and extensive therapeutic area knowledge.
Collaboration
Experience our collaborative and partner-centric approach that blends your insights with our expert writing services to produce tailored regulatory documentation.
Quality
Reduce revisions and accelerate approval timelines with our rigorous quality control processes and experienced writers that produce superior drafts that meet global regulatory standards.
Flexibility
Take advantage of our flexible staffing model that scales to match project demands, providing the regulatory experts required to meet your evolving needs without delay.
TALK TO A DEVICE REGULATORY WRITING CDx EXPERT
Whether you’re looking for a writing partner, or just want to price shop a potential project – we’d love to connect. Fill out the form and someone from our team will be in touch within one business day.
