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Technical documentation EU Authorized representative Clinical evaluation PRRC services Risk management Notified bodies Quality management system Post-market surveillance
General medical devices and equipment In vitro diagnostics (IVD) Medical Device Software (MDSW)
CE-marking process for medical devices CE-marking process for in vitro diagnostics MDR technical documentation checklist IVDR technical documentation checklist Technical documentation checklist for MDSW PRRC under MDR or IVDR
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Clinical evaluation


Clinical evaluation is needed to ensure regulatory compliance, assess safety and efficacy, manage risks, drive product development, monitor device performance, and enable evidence-based decision making in the field of medical devices.

Clinical evaluation can be a complex and time-consuming task. We can simplify the process for you.



General algorithm of clinical evaluation

1. Device identification 2. Identification of relevant GSPR 3. Identification of sources of clinical data 7. Scientific databases search 6. Analysis of clinical investigations 5. Establishing equivalence 4. Establishing state of the art 8. PMS & PMCF data analysis 9. Clinical benefits & foreseeable risks 10. Benefit / risk analysis

Clinical evaluation holds immense importance as it undergoes rigorous assessment by Notified Bodies, making it a critical aspect of the regulatory approval process for medical devices.

Don't let the complexity of clinical evaluation hold you back. Let us handle this critical task for you.

Send us an email:
info@mdrc-services.com

Or use the contact form below