Clinical Evaluation of Medical Devices Overview
Freyr extends its expertise as a trusted partner, ensuring compliance and excellence in the clinical evaluation of medical devices (for all classes). Specializing in comprehensive Clinical Evaluation services, Freyr emphasizes precision, Regulatory adherence, and strategic planning to meet the evolving requirements of the global markets.
Freyr’s End-to-End Clinical Evaluation Services
Freyr assists medical device manufacturers in developing a robust Clinical Evaluation Plan (CEP) tailored to their medical devices' class and specifications. Recognizing the crucial role of a well-defined CEP in meeting the required expectations of applicable regulations and ensuring the safety and performance of products, Freyr's experts derive a robust clinical strategy tailored to the claims and risk class. Collaborating with the stakeholders, the team ensures alignment with the device's intended use, clinical claims, and risk assessment, facilitating a comprehensive and compliant approach to clinical evaluation.
Freyr's systematic literature review services help in staying ahead of the curve by meticulously analyzing existing literature. Freyr provides a comprehensive overview of the clinical landscape, aiding evidence-based decision-making for your medical devices.
Freyr compiles the Summary of Safety and Clinical Performance (SSCP) as per the requirements of the EU MDR, ensuring thorough documentation of device safety and performance data, and enabling public access to relevant information.
Freyr’s Tailored Clinical Evaluation Services
Clinical Evaluation Gap Analysis
Identifying gaps in clients' current clinical evaluation process is key to maintaining compliance. Freyr's professionals conduct thorough gap analysis, pinpointing areas of improvement and enhancing the quality and reliability of clinical data.
Tailored Approaches of Literature Strategy Preparation
The development of customized literature search and review strategies tailored to each device and its intended use optimizes the identification and selection of relevant scientific literature to support clinical evaluation.
Subject Matter Expert (SME) Support for Non-conformities Review
Freyr's team of experienced Subject Matter Experts (SMEs) provides invaluable support in reviewing non-conformities, ensuring a meticulous assessment and resolution process. Collaboratively working with our partners' teams, Freyr addresses issues promptly and effectively.
SOP Writing
Freyr's SOP writing services help in establishing standardized procedures and protocols for clinical evaluation activities. This ensures consistency, efficiency, and compliance with Regulatory requirements.
Annual Maintenance of Clinical Reports
Freyr provides annual maintenance services for Clinical Evaluation Reports (CERs), ensuring the documentation remains up-to-date and compliant with Regulatory requirements, including the EU MDR.
Full-Time Employee Support
Freyr offers full-time employee support to assist medical device manufacturers in maintaining a dedicated team for clinical evaluation activities. This ensures consistent and dedicated resources, enhancing the efficiency and effectiveness of the evaluation process.
Procedural Trainings
Freyr offers procedural trainings to enhance a team's understanding and proficiency in clinical evaluation processes. This is to note that each organization has unique needs and challenges, which is why tailored trainings based on the specific requirements is crucial. Freyr’s comprehensive trainings cover various aspects of Regulatory compliance and best practices, empowering the team to navigate complex requirements with confidence and efficiency.
Freyr’s Clinical Evaluation Services
Regulatory Compliance
Freyr simplifies navigation of the complex landscape of the European Medical Device Regulations (EU MDR), ensuring your clinical evaluations align with the EU MDR requirements and helping you achieve and maintain compliance in the European Union (EU) market.
Specializing in catering to various international regulatory frameworks, including those of the United Kingdom (UK), CDSCO (Central Drugs Standard Control Organization), SFDA (Saudi Food and Drug Authority), and more, Freyr's services are designed to meet the unique demands of each region.
