easyClinical Supports Innovative MedTech Solutions
We help MedTech companies in both clinical evaluation and clinical investigation through generating robust clinical evidence to get their products authorized on the market and advancing patient care and medical innovation.
easyClinical supports innovators with all requirements for all risk classes of their device-Class, including Post market clinical follow-up (PMCF).
Clinical Evaluation
- Clinical Evaluation Report (CER)
- Clinical Evaluation Plan (CEP)
- Clinical Development Plan (CDP)
- PMCF Plan
- Post-Market Surveillance Plan (PMS)
- Periodic Safety Update Report (PSUR)
- Summary of Safety and Clinical Performance (SSCP)
- Claiming Equivalence
- Labeling
- Device Risk Management
Clinical Investigation
- Pre-market study
- Post-Market Clinical FU (PMCF) study
- Real-World data collection (retro prospective)
- PMCF Surveys
