A CER Process
That Fits Your Team
Work With Us On Your Terms
Have some great writing staff already? Or limited budget? Plug directly into our process and use our expertise only when you need it.
Full CERs End to End
Our team of Notified Body Acceptable CER writers can deliver a complete document
ready for submission.
Use Our Templates
Draft your new MDR CER from our templates. Complete training annotations, and Notified Body insights included.
More about our service
Our clinical evaluation services are designed to meet the stringent requirements of EU MDR. We assist you in developing and executing a comprehensive clinical evaluation plan, considering various sources of clinical data, such as clinical investigations, post-market surveillance, and literature reviews. Our experienced professionals meticulously analyze the collected data to generate a well-structured and scientifically robust Clinical Evaluation Report (CER).
Key Features of Our Clinical Evaluation Services:
Regulatory Compliance: The EU MDR places significant emphasis on demonstrating the safety and performance of medical devices. Our team ensures that your CER meets all the regulatory requirements and addresses the specific requirements outlined in the EU MDR.
Comprehensive Data Analysis: Gathering and analyzing clinical data is crucial to the CER writing process. Our team uses proprietary software to conduct thorough data analysis, including literature reviews, clinical investigations, post-market surveillance data, and other relevant sources. We ensure that your CER is based on robust scientific evidence.
Risk/Benefit Assessment: We conduct a thorough risk assessment from the clinical data to identify and evaluate potential benefits and hazards associated with your medical device. This will help you gauge the risk profile of your device and take the necessary actions required for mitigation.
State of the Art: Analyze the current state of the art in relation to the device, including alternative treatments or technologies available in the market.
Conclusions and Recommendations: Summarize the findings of the clinical evaluation and draw conclusions regarding the safety and performance of the device. Provide recommendations for further actions or improvements, if applicable.
Timely Delivery: We understand the importance of meeting deadlines. Our team works diligently to deliver your CER within the agreed-upon timeframe, without compromising on quality or accuracy.
Confidentiality: We prioritize the confidentiality of your data and ensure that all information shared with us remains secure and protected. You can trust us to handle sensitive information with the utmost care and professionalism.
Ongoing Support: Our commitment to your success goes beyond just writing the CER. We provide ongoing support and guidance throughout the entire process, including post-submission follow-ups and any necessary revisions or updates.
Partner with us for your EU MDR Clinical Evaluation Report writing needs and experience a seamless and efficient process.
More about our service
Our clinical evaluation services are designed to meet the stringent requirements of EU MDR. We assist you in developing and executing a comprehensive clinical evaluation plan, considering various sources of clinical data, such as clinical investigations, post-market surveillance, and literature reviews. Our experienced professionals meticulously analyze the collected data to generate a well-structured and scientifically robust Clinical Evaluation Report (CER).
Key Features of Our Clinical Evaluation Services:
Regulatory Compliance: The EU MDR places significant emphasis on demonstrating the safety and performance of medical devices. Our team ensures that your CER meets all the regulatory requirements and addresses the specific requirements outlined in the EU MDR.
Comprehensive Data Analysis: Gathering and analyzing clinical data is crucial to the CER writing process. Our team uses proprietary software to conduct thorough data analysis, including literature reviews, clinical investigations, post-market surveillance data, and other relevant sources. We ensure that your CER is based on robust scientific evidence.
Risk/Benefit Assessment: We conduct a thorough risk assessment from the clinical data to identify and evaluate potential benefits and hazards associated with your medical device. This will help you gauge the risk profile of your device and take the necessary actions required for mitigation.
State of the Art: Analyze the current state of the art in relation to the device, including alternative treatments or technologies available in the market.
Conclusions and Recommendations: Summarize the findings of the clinical evaluation and draw conclusions regarding the safety and performance of the device. Provide recommendations for further actions or improvements, if applicable.
Timely Delivery: We understand the importance of meeting deadlines. Our team works diligently to deliver your CER within the agreed-upon timeframe, without compromising on quality or accuracy.
Confidentiality: We prioritize the confidentiality of your data and ensure that all information shared with us remains secure and protected. You can trust us to handle sensitive information with the utmost care and professionalism.
Ongoing Support: Our commitment to your success goes beyond just writing the CER. We provide ongoing support and guidance throughout the entire process, including post-submission follow-ups and any necessary revisions or updates.
Partner with us for your EU MDR Clinical Evaluation Report writing needs and experience a seamless and efficient process.
Peace of Mind For Your Submission
Our team is built and trained to get your CER approved. Whether you need a complete service, or are just looking for some occasional doc review and literature support the CiteMed team is ready to jump in.
What’s included in a CiteMed CER?
Systematic Literature Review
Bring your own, use our software system, or let our experts conduct a bullet-proof SLR for your CER
EU MDR Template and Streategy
We focus exclusively on EU MDR, so you can be assured our template is audit-tested and ready.
Qualified Review
Worried your CV won’t be enough for your auditor? Our writers are all Notified Body approved for submission.
PMS Planning and Reporting
We advise, draft, and execute plans for PMS compliance on all device classifications. Have your own already? No problem.
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Are You Ready to Work With Us?
If You Are…
We might be a fit!
Notifed Body Approved Writers
Our writers have the chops to tackle any classification of device for MDR, and the CVs to submit alongside your final document. Our team has cumulatively written well into the 100s of CERs on all device classifications.
Consistent Updates If You Need Them
Keep your Literature Review, and CER documents updated year after year without worry or hassle. We keep everything organized and audit ready.
Post Market and Vigilance Data Support
If you have a team and process in place for PMS, great! If you don’t, our comprehensive PMS packages are easily integrated into your CER.
