In the ever-evolving world of medical device and in-vitro diagnostic (IVD) manufacturing, ensuring compliance with regulatory standards is paramount. At I3CGlobal, we specialize in assisting manufacturers with the preparation of high-quality Clinical Evaluation Reports (CER) and Performance Evaluation Reports (PER), paving the way for successful Notified Body clearance.
With a deep understanding of the complexities involved in regulatory processes, I3CGlobal has positioned itself as a trusted outsourcing partner for manufacturers worldwide. We offer tailored solutions that not only meet regulatory requirements but also ensure that your medical and IVD devices can reach the market without delays or complications.
Why Clinical Evaluation and Performance Evaluation Reports Matter
The Clinical Evaluation Report (CER) and Performance Evaluation Report (PER) are essential documents that demonstrate the safety, efficacy, and performance of medical devices and in-vitro diagnostic devices. They are critical components for securing approval in markets governed by stringent regulations such as the European Medical Device Regulation (MDR), In Vitro Diagnostic Regulation (IVDR), and other global frameworks.
Clinical Evaluation Report (CER):
A CER provides a comprehensive analysis of the clinical evidence that supports the safety and effectiveness of a medical device. It evaluates all relevant clinical data, including clinical trials, scientific literature, and post-market surveillance data. The CER is a key document for obtaining CE marking in Europe and other regulatory approvals worldwide.
Performance Evaluation Report (PER):
For in-vitro diagnostic devices (IVDs), the Performance Evaluation Report (PER) serves a similar function as the CER. It outlines the clinical evidence proving the performance, reliability, and safety of the IVD device. The PER is a necessary part of the IVDR compliance process.
Both reports are crucial for gaining Notified Body clearance, enabling manufacturers to demonstrate their commitment to safety and regulatory compliance, ensuring that their products are safe and effective for use in healthcare environments.
Our Expertise in CER and PER Consulting
At I3CGlobal, we leverage our extensive experience and deep regulatory knowledge to guide medical device and IVD manufacturers through the complex clinical evaluation and performance evaluation processes. Our services ensure that your CER and PER are thorough, accurate, and meet the highest regulatory standards, ensuring a smoother path to approval.
Here’s how we assist you:
Comprehensive Clinical and Performance Evaluation:
We begin with an in-depth review of the clinical and performance data available for your device. Our team will conduct a detailed literature search, analyze clinical trials, and evaluate existing evidence to ensure that all aspects of the device's safety and performance are fully documented.
Gap Analysis and Strategy Development:
We perform a gap analysis to identify any missing or insufficient data that may hinder the approval process. Based on this, we develop a comprehensive strategy to gather the necessary clinical or performance evidence to support your CER or PER.
Preparation of CER and PER:
Our team drafts a clinical evaluation report or performance evaluation report that complies with all applicable regulatory requirements. This includes adhering to the MDR, IVDR, and other standards, ensuring that the report is complete, accurate, and ready for submission.
Notified Body Engagement and Assistance:
We help you engage with Notified Bodies and regulatory authorities. We guide you through the process, from preparing for audits to responding to feedback, ensuring that your CER and PER support a smooth Notified Body clearance.
Ongoing Support and Post-Market Surveillance:
After Performance Evaluation the approval of your device, we continue to support you through post-market surveillance and updates to your CER or PER as new clinical or performance data becomes available. This ensures that your device remains in compliance throughout its lifecycle.
Why Choose I3CGlobal?
As a knowledge-driven and strategically located regulatory consulting firm, I3CGlobal offers dependable and expert services to medical device and IVD manufacturers. Here's why we're the right partner for your CER and PER needs:
Global Expertise:
Our team has vast experience working with medical device and IVD manufacturers worldwide. We understand the nuances of regulatory requirements in different regions, including the European Union, North America, and Asia-Pacific, ensuring your device meets the regulatory demands of your target markets.
Notified Body Clearance Assurance:
We understand that securing Notified Body clearance is crucial for your product's market access. With our proven expertise in preparing high-quality CERs and PERs, we offer a guarantee that your reports will meet the requirements of the relevant authorities, minimizing the risk of rejection.
Tailored Solutions:
Every device is unique, and so are its regulatory requirements. We provide personalized consulting services to address the specific needs of your product, whether you are dealing with high-risk devices or IVDs with complex performance requirements.
Long-Term Partnerships:
We aim to build long-term relationships with our clients by providing ongoing support throughout the product lifecycle. From initial regulatory consultation to post-market surveillance, we are with you every step of the way.
A Step Forward, Every Day:
At I3CGlobal, we are committed to helping you take your business to the next level. We work diligently to click here ensure that your regulatory compliance is robust, allowing you to focus on what matters most – delivering high-quality, safe, and effective devices to your customers.
Get Started with I3CGlobal Today
Navigating the complexities of Clinical Evaluation Reports (CERs) and Performance Evaluation Reports (PERs) can be challenging, but with I3CGlobal as your partner, you can be confident that you are in good hands. Our regulatory consulting team is ready to assist you in preparing these critical reports, ensuring that your devices comply with global standards and regulations.
Contact us today to learn how we can help you streamline the regulatory process and gain Notified Body clearance for your medical device or IVD. Let us assist you in taking that important step forward—every day, towards success.