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.

Leveraging our Clinical Evaluation Report (CER) with 1000 different kinds of devices, we can help you:

Our CER Expertise

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Experience Team

Our Expertise

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.

Wish to know more about Premarket Approvals | PMA Basics, supplements, amendments, QMS & More…

Our medical devices’ internal audit team can help you with -

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Our Services

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Post-Market Surveillance Reporting

Post-Market Surveillance Reporting

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Product Quality Monitoring

Product Quality Monitoring

We provide guidance on establishing quality control processes to monitor the consistency…

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Corrective and Preventive Actions (CAPA)

Corrective and Preventive Actions (CAPA)

In case of any product-related issues or non-compliance, we help you plan…

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Customized Post-Market Surveillance Plans

Customized Post-Market Surveillance Plans

We create tailored post-market surveillance plans to meet your specific product and…

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Product Recalls and Withdrawals

Product Recalls and Withdrawals

If necessary, we assist in planning and executing product recalls or withdrawals…

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Our Compliance Assessment Process

Our process begins with an in-depth consultation where we learn about your medical device, its intended use, and your specific goals. This helps us tailor our assessment to your unique needs.

Our team of experts is well-versed in global medical device regulations, including FDA submissions, CE marking, TGA requirement, Health Canada approvals, ISO, and more. We stay up-to-date with the latest changes in the regulatory landscape.

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We will conduct a comprehensive review of your existing documentation, including design files, clinical data, quality management systems, and risk assessments.

Our consultants will perform a gap analysis to identify any areas where your device may fall short of compliance. This forms the basis for our recommendations.

Based on our findings, we will provide you with detailed recommendations and a roadmap for achieving compliance. This may involve revising documentation, conducting additional testing, or making necessary design changes.

Our services don't stop with just the assessment. We offer ongoing support to guide you through the compliance process, helping you address any challenges that may arise.

Compliance Assurance

Stay compliant with industry regulations and standards.

Cost-effective

Achieve regulatory success with Elexes, all within your budget.

Why choose

Elexes for medical device regulatory & compliance services?

Quick Turn around

Experience timely results with our efficient services.

Confidentiality guaranteed

We offer 100% confidentiality understanding how critical the data is for you.

Elexes offer complete range of regulatory and compliance expertise, ensuring full-support in product development and post-market compliance. Get everything under one roof for your medical device!

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

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