Our Comprehensive CER Services include
Clinical Evaluation Plan (CEP) Development
We create a detailed CEP that outlines the strategy and methodology for your device’s clinical evaluation. This plan defines the scope of clinical data to gather (such as literature reviews and any necessary clinical studies), the criteria for appraising data, and the approach for analysis. Starting with a robust CEP ensures that the subsequent CER process is structured and MDR-compliant from the outset.
In-Depth Clinical Evaluations
We conduct thorough evaluations of your medical device by reviewing extensive clinical data gathered from clinical investigations and clinical studies.
Adherence to MDR Standards
Our CERs are fully compliant with MDR requirements, incorporating detailed assessments that align with General Safety and Performance Requirements (GSPRs).
Continuous Updating
Recognizing the dynamic nature of medical device regulation, we continuously update our CERs by integrating new clinical data, post-market surveillance outcomes, and any modifications to the device.
Gap Analysis
We perform detailed gap analyses on existing clinical evaluation (reports) to identify deficiencies and ensure your documentation meets current regulatory expectations.
Risk-Benefit Analysis
Our evaluations include comprehensive risk-benefit analyses that assess the device’s safety and efficacy within its intended clinical setting and patient population.
Detailed Clinical Evidence Compilation
Our experts compile and critically analyze clinical data from clinical studies, ensuring a complete understanding of the device’s performance and safety profile.
Expert Team Involvement
Our specialists bring deep expertise in medical device evaluation, clinical research, and regulatory affairs, ensuring the accuracy and validation of both our CERs and supporting CEP documentation.
WHY CHOOSE MDS FINLAND FOR CRA SERVICES?
Expertise in MDR Compliance
Our team is well-versed in the latest MDR guidelines, ensuring that our CERs not only meet regulatory requirements but also contribute to enhanced patient safety and medical innovation.
Tailored Evaluations
We understand that each medical device is unique. Our evaluations are customized to the specific characteristics and intended use of your device.
Proactive Approach
We continuously update our CERs and CEP in line with evolving clinical data and regulatory changes, keeping your documentation current and compliant.
At MDS Finland, our comprehensive approach—combining a robust Clinical Evaluation Plan with meticulously prepared Clinical Evaluation Reports—ensures that your device meets the highest standards of safety and efficacy, paving the way for successful market entry while upholding patient safety.
