YOUR REGULATORY CLINICAL MEDICAL DEVICE WRITING PARTNER
MEDICAL DEVICE WRITING SERVICES
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)
CRITERION EDGE
Criterion Edge was founded in 2016 with the goal to build a world-class team of industry experts dedicated to providing regulatory support and comprehensive writing services to pharma, biotech and device clients worldwide.
Today, Criterion Edge has grown into a recognized leader, trusted by clients ranging from ambitious start-ups to some of the largest companies in the world, but our dedication to quality, scientific rigor and regulatory excellence has not changed.
Laurie Mitchell, MN
President & Founder
A team of experts at your service
Medical Writers
PhD’s, MD’s, Scientists,
Researchers
Researchers
Project Oversight
Principal Writer / Strategic Leadership
Project Management
Project Manager
Literature Review Team
Medical Librarian, Clinical
Evidence Experts
Evidence Experts
Quality Assurance
Quality Assurance
Manager
Manager
Why Criterion Edge
Expertise
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
Collaboration
Experience our collaborative and partner-centric approach that blends your insights with our expert writing services to produce tailored regulatory documentation.
Quality
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
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.
Why Criterion Edge
Expertise
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
Collaboration
Experience our collaborative and
partner-centric approach that blends
your insights with our expert writing
services to produce tailored regulatory
documentation.
Quality
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
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.
How we exceed your expectations
Project Scoping & Planning
- Define the scope of the project
- Outline timelines for deliverables
- Clarify roles and responsibilities
- Establish communication channels with SMEs
Document Development
- Focused document development
- Proactive timeline management
- Collaborative engagement with stakeholders/SMEs
Review Process
- Roundtable leadership
- Management of action items
- Structured review reminders
Finalization & Delivery
- Client-tailored close out process
what to expect: continuous collaboration
Project Scoping & Planning
- Define the scope of the project
- Outline timelines for deliverables
- Clarify roles and responsibilities
- Establish communication channels with SMEs
Document Development
- Focused document development
- Proactive timeline management
- Collaborative engagement with stakeholders/SMEs
Review Process
- Roundtable leadership
- Management of action items
- Structured review reminders
Finalization & Delivery
- Client-tailored close out process
What our clients have to say
Survey Responses
Below are the average scores (out of 5) for each of the criteria we ask our clients to grade us on after every project.
Flexibility
0
Quality
0
Expertise
0
Timeliness
0
Collaboration
0
Communication
0
Overall
0
/ 5.00
TALK TO AN EXPERT
Whether you’re navigating a complex regulatory submission, preparing for an audit, or simply exploring outsourced support — our team is here to help.
Criterion Edge specializes in high-quality, compliant medical writing services for the life sciences industry. Use the form to tell us a bit about your needs — one of our experts will follow up within one business day.
Need a faster response? Use the chat icon in the lower-right corner to speak with us immediately during business hours.
- No obligation — just an open conversation
- Expert guidance from PhD-level writers
- Trusted by leading MedTech & Pharma companies
- Fast turnaround for time-sensitive projects
- Clear quotes and scoping available