Performance Evaluation of In Vitro Diagnostic (IVD) Devices Overview
Freyr specializes in providing comprehensive services tailored specifically for In Vitro Diagnostic (IVD) devices ensuring Regulatory compliance and optimal performance. The range of performance evaluation services that Freyr offers include
Freyr’s Performance Evaluation End-To-End Services
Freyr assists in developing a robust Performance Evaluation Plan (PEP) tailored to the specifications of IVDs ensuring compliance with Regulatory requirements and optimal performance assessment. Freyr excels in providing optimum strategy build-up for SaMDs.
Freyr compiles a Performance Evaluation Report (PER) in accordance with the requirements of the In Vitro Diagnostic Regulation (IVDR), ensuring thorough documentation of your IVD performance data.
Freyr's Scientific Validity Reports (SVR) provides an in-depth analysis of the scientific validity of their IVDs performance claims, along with a thorough analysis of the currently available guidelines.
The team at Freyr prepares Clinical Performance Reports (CPR), providing a comprehensive overview of IVDs clinical performance based on a rigorous and structured analysis of literature and evaluation.
Freyr compiles Analytical Performance Reports (APR), ensuring comprehensive documentation of IVDs’ analytical performance characteristics. Our team meticulously analyzes data, including precision, accuracy, sensitivity, specificity, and other relevant parameters, to provide a detailed assessment of the device's performance. By leveraging our expertise, IVD manufacturers can demonstrate the reliability and effectiveness of their IVDs to Regulatory authorities and stakeholders.
- For Immunohistochemistry (IHC) assays, Freyr offers assistance in documenting sample reports for IVDs obtained from Nordic Immunohistochemical Quality Control (NordiQC).
- Freyr prepares Trueness Reports, offering an assessment of the accuracy and reliability of IVDs’ measurements.
Freyr offers specialized services for drafting Summaries of Safety and Performance (SSP) for Class C and D medical devices, excluding those intended solely for performance studies. Our team ensures clarity in the SSP, catering to both the intended user and, where relevant, the patient, as mandated by Regulatory standards. We facilitate the inclusion of essential aspects mandated by regulations, such as device identification, intended purpose, description, references to standards, performance evaluation summaries, and metrological traceability.
Freyr’s Performance Evaluation Tailored Services
Performance Evaluation Gap Analysis
Identifying gaps in current performance evaluation/clinical performance processes specific to In vitro Diagnostic (IVD) devices is crucial for maintaining compliance. Freyr's experts conduct meticulous gap analyses tailored to the unique requirements of IVDs, pinpointing areas for improvement and enhancing the quality and reliability of clinical data to meet Regulatory standards.
Tailored Literature Strategy Preparation
Freyr specializes in developing customized literature search and review strategies specifically tailored to each IVD and its intended use. This optimization process ensures the identification and selection of relevant scientific literature to support the performance evaluation of IVDs, specially in reports like Post-market Performance Follow-up (PMPF), clinical performance report, establishment of the State-of-the-Art (SOTA), etc.
Subject Matter Expert (SME) Support for Non-Conformities Review
Freyr's team of experienced Subject Matter Experts (SMEs) offers invaluable support in reviewing non-conformities across all the clinical documentation. With expertise in IVD technologies and Regulatory requirements, a meticulous assessment resolves issues, collaboratively working with your teams to ensure prompt and effective resolution.
SOP Writing
Freyr's SOP writing services are tailored to IVDs and aim to establish standardized procedures and protocols for clinical evaluation activities. These SOPs ensure consistency, efficiency, and compliance with Regulatory requirements, streamlining processes and enhancing overall quality management for IVD development and Regulatory submissions.
Life Cycle Management of Clinical Reports
Freyr provides annual maintenance services for Performance Evaluation Reports (PER), including Clinical Performance Reports (CPR), scientific validity, etc., ensuring the documentation remains current and compliant with Regulatory requirements. Our team conducts thorough reviews and updates to reflect any changes in regulations, standards, or device performance data, guaranteeing ongoing adherence to Regulatory expectations and market demands.
Full-Time Employee Support
Freyr offers dedicated full-time employee support to assist you in maintaining a specialized team for performance activities. By providing consistent and dedicated resources, we enhance the efficiency and effectiveness of the evaluation process, ensuring continuous compliance and quality management throughout the product lifecycle.
Procedural Trainings
Freyr conducts procedural trainings tailored to the unique needs and challenges of organizations involved in IVD development and Regulatory compliance. Our comprehensive trainings cover various aspects of performance evaluation processes, Regulatory compliance, and best practices, empowering teams with the knowledge and skills necessary to navigate complex requirements with confidence and efficiency. Through customized training programs, we address specific organizational requirements, enabling teams to effectively manage clinical evaluation activities and maintain compliance with Regulatory standards.
Freyr’s Performance Evaluation Services
Therapeutic Areas of Excellence
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