What is clinical evaluation report?
Clinical Evaluation Report (CER) for medical devices is a document that needs to be created and updated during a medical device’s lifespan. The CER must include inputs from risk management, verification testing, literature review and clinical investigations.
It is critical as per the regulatory requirements that CER file should to be updated and revised whenever there is any change in the device
We, at Elexes Medical Device Consulting have a team of experts who will help you prepare Clinical Evaluation Report (CER) for your medical device.
CER throughout the medical device life-cycle
The initial Clinical Evaluation Report (CER) is prepared during the development phase of the device which is carried out even after the launch of the product. Post launch, it is important that the report is updated regularly based on the post-market surveillance, newly discovered risks or indications and developments in the clinical fields.
Our experts will help you identify insufficiencies, determine inspection readiness, and evaluate risks, smoothing the inspection process and providing a greater chance of successful inspection. We will conduct periodic internal audits to ensure compliance with all the applicable ISO standards, cGMPs and internal regulations. Be it short targeted internal audits or more sustainable assessments across the quality management system (QMS), we have experts who can conduct a thorough audit and come up with any compliance gap that needs to be worked on.
Our medical devices’ internal audit team can help you with -
Our Compliance Assessment Process
Our team of regulatory experts is well-versed in global cosmetic packaging regulations and has a proven track record of ensuring compliance.
We understand that each cosmetic product packaging is unique. Our solutions are tailored to your specific needs.
Why Choose Elexes?
We work diligently to provide timely results, ensuring your products' packaging meets compliance requirements promptly.
Our comprehensive assessments and recommendations help you maintain compliance and avoid potential legal issues.
We handle your product and packaging information with the utmost confidentiality and adhere to strict privacy standards.
We, at Elexes have experts who will assist you in creating, maintaining, and updating your product’s Clinical Evaluation Report (CER).
So, if you are looking for support, all you got to do is
Our New Product Approval Service Corner
We offer different services that will help you not only keep your product well in boundaries of regulations but also speed up the entire approval process. Some of these services are -
Associated Regulatory Authorities.
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