Clinical evaluation is key to building trust in MedTech. At Qualentra Global, we help device companies demonstrate safety, performance, and compliance through evidence-based evaluations. Our ISO 14155 and MEDDEV-aligned services streamline CE marking and global approvals, while our CRO partnerships support clinical trials for data generation.
- Clinical Evaluation Report (CER) Development (as per MDR & MEDDEV 2.7/1 Rev. 4)
- Literature Review Strategy & Execution
- Equivalence Assessment & Justification
- Post-Market Clinical Follow-up (PMCF) Planning
- Clinical Risk-Benefit Analysis
- Clinical Trial Support
End-to-End Lifecycle – 6 Stages of Clinical Evaluation
Scoping & Data Mapping
Define intended use, device claims, and map available clinical and scientific evidence.
Literature Search & Critical Appraisal
Conduct systematic reviews using pre-approved protocols aligned with MDR standards.
Equivalence & Comparator Justification
Assess similar devices for data bridging based on clinical, technical, and biological characteristics.
Clinical Data Analysis & Risk-Benefit Evaluation
Analyze internal studies, literature, and real-world data to substantiate safety and performance claims.
CER Drafting & PMCF Planning
Prepare a compliant Clinical Evaluation Report and define PMCF activities as needed.
Clinical Trial Coordination
For higher-risk devices or novel technologies, we facilitate clinical investigations through contract research organizations (CROs) to generate new data.
100%
Regulatory-Compliant CERs Delivered
50%
Faster Literature Review & CER Turnaround
60days
Successful Trial Setup Completion
Frequently asked questions
Yes, we coordinate clinical trials through a network of qualified CROs, managing study design, site selection, ethics submissions, and data reporting.
Sometimes. For legacy or low-risk devices, literature and equivalence may be adequate. For innovative or higher-risk devices, additional data—often via clinical studies—is required.
Under EU MDR, CERs must be updated periodically (every 1–5 years depending on risk class) and after any significant change, new clinical findings, or safety event.