Ensuring clinical safety, performance, and regulatory compliance is critical for medical devices and in-vitro diagnostics (IVDs). Simplimedica provides expert Clinical Evaluation & Performance Evaluation Services , supporting manufacturers in demonstrating robust clinical evidence, meeting EU MDR, EU IVDR, and UKCA regulatory requirements.
Our team combines regulatory expertise, clinical research experience, and technical knowledge to deliver clear, compliant, and audit-ready documentation that accelerates approvals and ensures patient safety. With Simplimedica’s Clinical Evaluation & Performance Evaluation Services, your organization benefits from a structured, risk-based approach to clinical evidence generation.
Regulatory bodies require that every medical device or IVD demonstrates clinical safety, performance, and effectiveness through rigorous evaluation. Failing to provide comprehensive clinical evidence can result in delays, non-compliance findings, or denied market access.
Simplimedica’s Clinical Evaluation & Performance Evaluation Services provide:
By leveraging our services, manufacturers can ensure that devices are safe, effective, and compliant throughout their lifecycle.
Under the EU MDR (2017/745) and UKCA requirements, every medical device must demonstrate clinical safety and performance. Simplimedica’s Clinical Evaluation Services cover the full spectrum of clinical evaluation activities.
We create a comprehensive Clinical Evaluation Plan (CEP) detailing your device’s clinical strategy, data sources, safety endpoints, and evaluation procedures. This structured approach ensures compliant clinical evidence generation for Notified or Approved Bodies.
Our systematic literature reviews follow international methodologies, are fully traceable and reproducible, and align with MEDDEV 2.7/1 Rev.4 and MDR Annex XIV. Simplimedica’s Clinical Evaluation Services ensure all relevant published and unpublished data are included.
We define the clinical context, assess alternative therapies or devices, and establish benchmark performance criteria. This demonstrates your device’s clinical positioning relative to current medical practice and supports regulatory evaluation.
 As part of Simplimedica’s Clinical Evaluation & Performance Evaluation Services, our team critically evaluates all clinical data—internal, external, and post-market—to provide a balanced, unbiased assessment of device safety, performance, and clinical benefits for regulatory submissions.
We prepare a fully compliant CER ready for submission, including evidence gaps, risk–benefit analysis, and integration with post-market surveillance (PMS) and post-market clinical follow-up (PMCF) requirements.
Simplimedica develops and implements PMCF Plans and Reports to ensure continuous evidence generation, regulatory compliance, and maintenance of your device’s safety and performance throughout its lifecycle.
The EU IVDR significantly increases the clinical evidence requirements for IVDs. Simplimedica’s Clinical Evaluation & Performance Evaluation Services guide manufacturers through analytical validation, scientific validity, and clinical performance assessments.
We design a complete Performance Evaluation Plan (PEP) that aligns scientific validity, analytical performance, and clinical performance requirements according to IVDR Annex XIII, ensuring a structured and compliant approach for your IVD products.
We collect and critically evaluate evidence linking the analyte to the clinical condition. Systematic literature reviews and data appraisal ensure clear, reproducible, and scientifically valid justification for your IVD’s intended use.
As part of Simplimedica’s Clinical Evaluation & Performance Evaluation Services, we define and manage studies covering accuracy, precision, sensitivity, specificity, LoD, LoQ, reproducibility, and interference testing. These analyses ensure your IVD meets stringent regulatory performance standards.
We plan and oversee clinical performance studies or assess existing data to demonstrate diagnostic sensitivity, specificity, and accuracy. Our services ensure regulatory compliance and efficient use of resources.
A comprehensive, audit-ready PER is prepared, detailing scientific validity, analytical performance, clinical results, and benefit-risk evaluation. This ensures full documentation for regulatory submissions and inspections.
We develop PMPF plans and reports to maintain ongoing evidence generation throughout the IVD lifecycle, supporting continued compliance, patient safety, and regulatory readiness after market launch.
Whether you need a single Clinical Evaluation Report (CER) or Performance Evaluation Report (PER), a full MDR/IVDR evidence package, or ongoing support for PMS, PMCF, or PMPF, Simplimedica provides the expertise, clarity, and structured approach required to achieve regulatory compliance efficiently. We work closely with clients to ensure that all evaluations are accurate, complete, and aligned with regulatory expectations, helping you stay audit-ready at every stage.
Our Clinical Evaluation & Performance Evaluation Services are specifically designed to guide medical device and IVD manufacturers through complex regulatory requirements. We help organisations navigate the full compliance landscape, reduce time-to-market, and avoid delays caused by incomplete or non-compliant documentation.
Simplimedica offers expert regulatory, clinical, and quality services for seamless medical device and IVD submissions:
End-to-end support: From CEP/PEP planning to CER/PER submission.
Experienced professionals: Specializing in MDR and IVDR evidence requirements.
Audit-ready documentation: Trusted by Notified Bodies and regulators.
Expertise across all device and IVD classes: Tailored support for all risk levels.
Efficient approval pathways: Streamlined process to reduce time-to-market.
By using our Clinical Evaluation & Performance Evaluation Services, you gain confidence that your clinical evidence strategy is compliant, robust, and aligned with regulatory expectations.
