- Regulatory Gap Analysis
- Device suitability for therapeutic use; certification and re-certification of medical devices (CE marking, labeling, conformity assessments, import approvals)
- Presence of Systems for Compliance – Quality management system – QMS (gap analysis and implementation), Post-market surveillance system, Clinical evaluation and post-market clinical follow-up (PMCF) system, Vigilance system, Risk management system
- Labeling and unique device identification (UDI) implementation and maintenance
- EUDAMED submissions
- Economic Operator (EO) assessment
- Importer, distributor compliance
- Assessment of Design History Files
Processes and People
- Clinical evaluation process
- Technical document and GSPR prep that meet EU MDR regulations based on device risk class
- Toxicologists to support biocompatibility risk assessment
- Human factor engineers to support usability studies