Criterion Edge
Criterion Edge is a global provider in the MedTech industry, dedicated to advancing compliance and market success for Medical Device, Pharma, and IVD companies through expert regulatory, scientific, and clinical writing services. They focus on helping clients navigate the regulatory landscape, ensuring compliance, and supporting product lifecycle management.
Industries
Nr. of Employees
small (1-50)
Criterion Edge
San Luis Obispo, California, United States, North America
Services
Authoring clinical evaluation reports, technical documentation, clinical study reports, and post-market clinical follow-up documentation to support device regulatory submissions.
Regulatory and scientific writing services for pharmaceutical and biologic products, including clinical study reports and submission dossiers.
Preparation of performance evaluation reports (PER), scientific validity reports, and support for IVDR compliance activities including PMPF planning.
Protocol-driven literature searches, data extraction, critical appraisal, and synthesis to support CERs and other regulatory documents.
Lifecycle regulatory strategy, quality system alignment, gap analysis for MDR/IVDR/MDSAP readiness, and notified-body interaction support.
Project matrices, milestone tracking, version control, internal training materials, and post-project reviews for multi-author regulatory programs.
Authoring clinical evaluation reports, technical documentation, clinical study reports, and post-market clinical follow-up documentation to support device regulatory submissions.
Regulatory and scientific writing services for pharmaceutical and biologic products, including clinical study reports and submission dossiers.
Preparation of performance evaluation reports (PER), scientific validity reports, and support for IVDR compliance activities including PMPF planning.
Protocol-driven literature searches, data extraction, critical appraisal, and synthesis to support CERs and other regulatory documents.
Lifecycle regulatory strategy, quality system alignment, gap analysis for MDR/IVDR/MDSAP readiness, and notified-body interaction support.
Project matrices, milestone tracking, version control, internal training materials, and post-project reviews for multi-author regulatory programs.
Expertise Areas
- Regulatory writing for medical devices, pharmaceuticals, and IVDs
- Clinical evaluation and CER/PER/PMCF program development
- Post-market surveillance and periodic safety/performance reporting
- MDR and IVDR compliance strategy
Key Technologies
- Systematic literature review (SLR) methodologies
- Clinical evaluation methodologies and state-of-the-art assessment
- Post-market surveillance systems and PMCF data collection methods
- Regulatory submission dossier preparation processes
News & Updates
Discussion on the implications of the revision 4 of MedDev 2.7/1 and upcoming MDR changes, especially on clinical evaluation reports.
Discussion on the implications of the revision 4 of MedDev 2.7/1 and upcoming MDR changes, especially on clinical evaluation reports.