MEDICAL DEVICE
Enhancing Market Success for Medical Device
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.
Systematic Literature Reviews
- Literature Search and Screening
- PRISMA Flowcharts
- Evidence Weighting & Appraisals
- Literature Review Reports
- Data Extraction Tables & Analyses
- Post-Market Literature Surveillance
Regulatory and Clinical Writing
- EU MDR Submission Plans & Reports
- Clinical Development Plans
- Instructions for Use (IFU)
- Post-Market Surveillance Plans & Reports
- KOL Podium & Writing Support
- Risk Management Reports
- SOTA Safety & Performance Measures
Scientific and Technical Documentation
- Clinical Evaluation Documentation
- Report Template Review & Development
- Publication & Datavision Support
- Risk Analysis & Management Documents
- Regulatory Document Gap Analysis
- Safety & Clinical Performance (SSCP)
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 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.
