Navigating the regulatory landscape for medical devices and in-vitro diagnostic (IVD) products can be complex, especially when it comes to ensuring that your product meets all required standards. At I3CGlobal, we specialize in providing comprehensive services for preparing Clinical Evaluation Reports (CER) and Performance Evaluation Reports (PER), ensuring your devices are compliant with global regulatory requirements, particularly Notified Body clearance.
Our team of experienced consultants, based in Bangalore, India, has been helping leading medical device manufacturers across the globe prepare high-quality clinical and performance evaluation reports. We understand the importance of these reports in the regulatory process, and our goal is to guide you through the process with expertise and efficiency, ensuring a smooth approval for your products.
The Role of CER and PER in Regulatory Compliance
Both Clinical Evaluation Reports (CERs) and Performance Evaluation Reports (PERs) play a pivotal role in the approval and market access of medical devices and IVDs. These reports are critical to demonstrate that your product meets safety, effectiveness, and performance requirements laid out by regulatory bodies such as the European Medicines Agency (EMA) and the MHRA.
Clinical Evaluation Reports (CER):
A CER is a systematic and critical review of the clinical data available for your medical device. This includes evaluating clinical trials, literature reviews, and post-market surveillance to prove that the device performs as intended and is safe for use. It is a key requirement for obtaining the CE Mark and complying with Medical Device Regulation (MDR) in Europe.
Performance Evaluation Reports (PER):
For in-vitro diagnostic devices (IVDs), the PER serves a similar function, providing evidence that the device meets the In Vitro Diagnostic Regulation (IVDR) requirements. The PER evaluates clinical data, laboratory test results, and performance characteristics, ensuring the device is safe, effective, and reliable.
Both reports need to align with the European Union's regulatory frameworks to guarantee that your product complies with legal and safety standards.
Why Choose I3CGlobal for Your CER & PER Needs?
At I3CGlobal, we offer in-depth expertise to guide you through the complex process of creating robust Clinical Evaluation Reports (CER) and Performance Evaluation Reports (PER). Our consultants are equipped with the knowledge, experience, and resources necessary to meet the highest standards in regulatory compliance, ensuring your medical device or IVD is ready for market approval. Here’s how we can help:
Experienced Consultants Performance Evaluation with Global Expertise
Our team of consultants has worked with medical device and IVD manufacturers worldwide, ensuring that our approach is tailored to meet the regulatory requirements of different regions, including Europe, the United States, and Asia. We help manufacturers navigate the complexities of regulations, such as MDR, IVDR, and FDA.
Comprehensive Clinical and Performance Data Analysis
We begin by reviewing all available clinical and performance data for your device, including clinical studies, scientific literature, and post-market surveillance data. Our experts perform a detailed gap analysis to identify any missing information or data that needs to be collected to meet regulatory requirements.
Customized CER and PER Preparation
Once the data is analyzed, we prepare a clinical evaluation report (CER) or performance evaluation report (PER) that meets the specific needs of your device and the applicable regulations. We ensure that these reports are complete, accurate, and in full compliance with EU MDR, IVDR, and other relevant standards.
Notified Body and Regulatory Liaison
We understand the importance of Notified Body interaction in the regulatory process. Our team works closely with Notified Bodies, guiding you through each step of the process—from submission to feedback resolution. With our expertise, we ensure that your CER and PER are designed to support a smooth clearance process.
Ongoing Post-Market Support and Updates
Regulatory compliance doesn’t end with market approval. We offer continuous support by updating your CER and PER as new clinical or performance data becomes available. We also provide post-market surveillance services to ensure ongoing compliance throughout the lifecycle of your product.
Benefits of Partnering with I3CGlobal
Global Reach, Local Expertise:
While our team is IVDR Performance Evaluation based in Bangalore, India, we serve clients across the globe. Our international experience allows us to navigate the regulatory requirements of multiple markets, ensuring compliance with regional standards and reducing time-to-market for your devices.
Regulatory Clarity and Guidance:
We offer clear and actionable guidance throughout the regulatory process, helping you understand the clinical evaluation and performance evaluation requirements for your device, as well as how to collect the necessary data and draft the required reports.
Notified Body Readiness:
With our extensive experience in preparing high-quality CERs and PERs, we ensure that your reports will meet the stringent requirements set by Notified Bodies and regulatory agencies, minimizing the chances of delays or rejections.
Comprehensive Documentation Support:
Our services extend beyond the preparation of CERs and PERs to include a wide range of regulatory documentation, ensuring your device is fully compliant with all applicable regulations.
Take the Next Step with I3CGlobal
The process of preparing Clinical Evaluation Reports (CERs) and Performance Evaluation Reports (PERs) is critical for the success of your medical device or IVD. At I3CGlobal, we are committed to making this process as smooth and efficient as possible, ensuring your device meets the highest standards of safety and performance.
Our expert team is ready to assist you every step of the way, from gathering clinical data to preparing the final reports for submission to Notified Bodies. Whether you are a small start-up or a large medical device manufacturer, we offer customized solutions that cater to your unique needs.
Contact us today to learn more about how we can support your regulatory journey and help you achieve market success with confidence. Together, let’s take your product through the regulatory maze and onto the market with a compliant and high-performing solution.