Your EU-MDR Clinical Evaluation

CERs written for you, or with you
to achieve EU MDR Compliance.
We guarantee your submission’s acceptance.

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.

The Only CER Team You’ll Ever Need

Our team is built and trained to get your CER approved, guaranteed.   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.

Medical Device Vigilance
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.

Are You Ready to Work With Us?

If You Are…

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!

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.

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.

What Our Clients Say

I was blown away by their responsiveness and service. They understood my urgency and got on the phone the same day I inquired.
Jen S. , Quality Director
Their approach to SLR is sound, and consistent. I love knowing that updates will be handled for us the next few years

VP of Regulatory Affairs
It was a huge advantage being able to leverage their experience on our final round of audit responses. Thanks again!
Regulatory Engineer , Device Manufacturer
Our lit review project was completed on-time, in only 3 weeks! Despite some bumps, CiteMed delivered
Director of QA/RA , Device Manufacturer
I loved the weekly update reports with just the right amount of detail. The ‘timeline risk rating’ was really helpful and made us feel comfortable throughout the project

Device Manufacturer, VP of Quality
The writers really got into our device, and listened to feedback. The level of detail was a huge help in our CER drafting process.
Quality Consultant , EU MDR Project Lead
CERs are the bane of my existence! Being able to pass them all off to CiteMed’s hands was a massive sigh of relief for me and my employees
CEO of Device Manufacturer

Get Ahead of Your Timeline.  Start Today