Welcome to Patient Guard, your go to partner for comprehensive medical device regulatory consultancy. With a proven track record of excellence and a commitment to regulatory compliance, we specialize in providing tailored solutions to meet the diverse needs of our clients in the healthcare industry. Our Clinical Evaluation Services are designed to support manufacturers in navigating the complex regulatory landscape, ensuring that their medical devices meet the highest standards of safety and performance.
Clinical evaluation is a cornerstone of the regulatory process for medical devices, playing a pivotal role in demonstrating products safety and effectiveness. At Patient Guard, we understand the critical importance of conducting thorough and robust evaluations in accordance with the stringent requirements outlined in EU Medical Device Regulations (MDR) 2017/745 and UK Medical Device Regulations 2002.
Our team of regulatory experts possesses the knowledge, expertise, and experience necessary to guide manufacturers through every stage of the process, from developing comprehensive Clinical Evaluation Plans (CEPs) to preparing detailed Clinical Evaluation Reports (CERs).
It is a fundamental process in the regulatory pathway for ensuring the safety and performance of medical devices. It involves the systematic assessment of clinical data to demonstrate that the device meets its intended purpose and benefits patients without posing unacceptable risks. This comprehensive evaluation is crucial for obtaining regulatory approval and market access for medical devices.
The process begins with the identification of the device’s intended use and intended patient population. This step is essential for defining the scope of the evaluation and determining the clinical data requirements. Manufacturers must clearly define the device’s intended use, indications for use, and target patient population to guide the selection of appropriate clinical data sources and methodologies.
Once the intended use and patient population are established, manufacturers conduct a thorough review of existing clinical data relevant to the device. This includes published literature, clinical studies, post-market surveillance data, and any other available sources of clinical evidence. The goal is to gather comprehensive and robust clinical data to support the safety, efficacy, and performance of the device.
The process involves several key steps, including:
Manufacturers collect and compile clinical data from various sources, including clinical investigations, literature reviews, post-market surveillance, and registries. The data collected should be relevant, reliable, and representative of the device’s intended use and patient population.
Once the clinical data is collected, it is systematically analyzed to assess the device’s safety, efficacy, and performance. This involves evaluating the clinical outcomes, adverse events, and other relevant parameters to determine the overall benefit-risk profile of the device.
Manufacturers conduct a thorough risk assessment to identify and evaluate any potential risks associated with the device. This includes assessing the probability and severity of adverse events and evaluating the mitigating measures in place to minimize risks.
The findings of the evaluation are documented in a CER. The CER provides a comprehensive summary of the clinical data, analysis, and conclusions, demonstrating the device’s conformity with regulatory requirements.
The process is not a one-time event but rather an ongoing process. Manufacturers are required to continuously monitor and update the clinical evaluation as new data becomes available or changes occur in the device’s intended use or patient population.
Effective evaluation requires expertise in clinical research methodology, regulatory requirements, and medical device technology. Manufacturers often rely on interdisciplinary teams of clinicians, scientists, regulatory affairs professionals, and statisticians to conduct a thorough and objective evaluation of the device.
Regulatory bodies, such as the European Medicines Agency (EMA) and the Food and Drug Administration (FDA), have established guidelines and requirements for conducting clinical evaluations of medical devices. These guidelines outline the principles and best practices for collecting, analyzing, and reporting clinical data to support regulatory submissions.
In the European Union (EU), the Medical Device Regulation (MDR) 2017/745 mandates that medical device manufacturers perform clinical evaluations to demonstrate compliance with safety and performance requirements. The MDR emphasizes the importance of using clinical data to assess the safety and performance of medical devices throughout their lifecycle.
Similarly, in the United States, the FDA regulates medical devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The FDA requires manufacturers to provide clinical data to support the safety and effectiveness of medical devices, especially for high-risk devices.
A well-defined and meticulously crafted CEP serves as the foundation for conducting a successful evaluation. Our team works closely with manufacturers to develop customized CEPs that align with their specific device and intended use. We take into account factors such as device classification, intended population, and available clinical data sources to create a comprehensive plan that meets the requirements of EU MDR 2017/745 and UK Medical Device Regulations 2002.
The CER is a comprehensive document that summarizes the results of the clinical evaluation and demonstrates the conformity of the medical device with regulatory requirements. Our regulatory experts are adept at preparing detailed CERs that meet the rigorous standards set forth by EU MDR 2017/745 and UK Medical Device Regulations 2002. We conduct thorough reviews of clinical data, analyze relevant literature, and provide evidence-based conclusions to support the safety and efficacy of the device.
Our team comprises seasoned regulatory professionals with extensive experience in medical device. We stay up-to-date with the latest regulatory developments to provide our clients with accurate and timely guidance.
We understand that every medical device is unique, and we tailor our evaluation services to meet the specific needs and requirements of each client. Whether you are a small start-up or a multinational corporation, we provide personalized solutions to help you achieve regulatory compliance.
Compliance is our top priority. Our evaluation services are designed to ensure that our clients’ medical devices meet the highest standards of safety and performance, as mandated by EU MDR 2017/745 and UK Medical Device Regulations 2002.
We understand the importance of timely regulatory submissions and market approvals. Our streamlined processes and proactive approach enable us to deliver high-quality clinical evaluation services efficiently and effectively, helping our clients bring their products to market faster.
We view our clients as partners in success. Our goal is to build long-term relationships based on trust, transparency, and mutual respect. We are committed to supporting our clients throughout their regulatory journey, from initial concept to market launch and beyond.
Tracey Slater, Cormed
Post-market surveillance (PMS) is a pivotal aspect that governs the continued monitoring and assessment of medical devices after they have
Medical device clinical evaluation is an essential part of regulatory compliance. Clinical Evaluation is a review of all the data
When developing a new and exciting product it can be hard to know if it might fall under specific regulations.
Medical Device Consultancy provides tailored expertise to your business, helping to navigate the medical device industry.
With advancements in technology,
Patient Guard Limited:
Lancaster House,
Amy Johnson Way,
Blackpool, Lancashire FY4 2RP
Patient Guard Europe UG:
Hauffstr. 41, 73765 Neuhausen,
Deutschland / Germany
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