Get a quote today – Drop us a line below and we’ll reach out with:
An overview of our CER process (and why it’s been so successful)
A link to book a optional free call with one of our founders (to talk through your challenges, and goals of your next CER project)
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.
100% Success Rate
How We Do It:
We are one of the only writing teams out there confident enough to guarantee our work. But before you roll your eyes and mutter “Nothing’s guaranteed in Regulatory Affairs”… hear us out.
We only work with great products and even better teams: If your device or submission is headed for disaster because of unrealistic claims fraudulent clinical data, or if your team is full of jerks… we won’t be able to help.
You get support through the entire audit: We don’t just zip up a pile of documentation and send you on your way. All of our projects include free consulting hours to address Auditor feedback, and ensure your get through successfully.
See our track record for yourself: We have extensive lists of reference. Drop us a line and we’d be glad to put you in touch with clients who saw success using our team/methods.
Delivered On Your Timeline
By the time they start, We have already finished.
Our process slashes your timelines, budgets and boosts CER writing productivity. All while delivering a product that is more consistent, thorough, and higher quality than the competition.
Notified Body Audits are tough to navigate on your own. Benefit from our teams countless submission successes and experience in drafting precise responses for all rounds of your Audit.
Dedicated Writing Team
Not all medical writers are created equal… which is why we hang on to our team of experience writing leads for dear life!
Our writing team is experienced, with cumulative 100s of successful documents authored and submissions navigated for clients.
Our writing team is qualified, all writers meet the Notified Body and EU Standards for a Clinical Reviewer/Author
Our writing team is diverse, dotting the globe geographically, and in terms of international regulatory requirements, you won’t find a more robust team.
Your Worry-Free Clinical Evaluation Report
EU MDR Compliant
Leave no doubt your submissions contains all the required components of MDR. Our templates have been continuously refined based on continued submission success, and Notified Body feedback.
Industry Leading Timelines
Have a major backlog of tech files? Or a response deadline looming? We boast the fastest timelines (5 Weeks Possible) and most consistent writing capacity of anyone in the industry.
Our track record speaks for itself. All writers have EU acceptable CVs and stacks of successful submissions to back up their opinions.
Long Term Management
Our team stays with you after you submit (if you want them to), and can manage all updates, literature, and PMS activities year after year to keep your devices compliant.
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.
EU MDR compliant CERs
Classes I, IIa, IIb & III
Specialists in SaMD
Free audit support hours for your entire submission
5 week delivery available
Calgary Scientific "It definitely met my return on investment expectations." Chris Slaymaker General Manager, Healthcare Hunter Healthcare "We weren't just looking for someone afforable, but also able to give us a quality product. Otherwise we wouldn't have kept working with CiteMedical." Haleema Ahmed International Regulatory Affairs Specialist Venus Concept "You actually get more than what you pay for." Sylvia Wilkinson Director, Regulatory Affairs and Quality Assurance Circa Scientific "It allowed us to keep within our budget for regulatory expenses, without having to stop selling in Europe, basically!" Quality Assurance Manager Channel Medsystem "[CiteMed] was very responsive and adherent to the timeline we had all agreed upon. It was excellent!" Director, Clinical and Regulatory Affairs Calgary Scientific "We suggested the cadence for meetings and that was kept up throughout the project and we had additional calls at very short notice, when we need to." Chris Slaymaker General Manager, Healthcare Circa Scientific "The deliverables captured the whole requirements of the EU MDR regulations." Quality Assurance Manager Venus Concept "CiteMed is very fun! They're very self starting, self efficient...CiteMed could take it and run with it!" Sylvia Wilkinson Director, Regulatory Affairs and Quality Assurance Channel Medsystem "By the time Citemed had already provided me with the SOW/quote, I was still sorting through NDAs and initial intake calls with other companies. The timeliness and urgency with which you were able to get started was the critical factor for me because we were on a really short timeline." Director, Clinical and Regulatory Affairs Calgary Scientific "I felt that the pricing was fair for the amount of work involved." Chris Slaymaker General Manager, Healthcare Venus Concept "The timelines and level of service I got from CiteMed exceeded all expectations." Sylvia Wilkinson Director, Regulatory Affairs and Quality Assurance
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 Strategy
We focus exclusively on EU MDR, so you can be assured our template is audit-tested and ready.
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.
Start Today – See Our CER and Get a Quote
View the intricate details of our writing process, our experience and qualifications, and our unheard of guarantee.
Short on staff and resources to write and maintain Clinical Evaluation Reports and Systematic Literature Reviews.
Perfectionists that want a consistent system and operating procedure to keep your CER compliant with MDR year after year.
In need of a single centralized platform to securly store your scientific literature, review and trending data over time (for easy updates and audits)
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.