We are MDR and IVDR Regulatory experts

Helping medical device Manufacturers get their devices to market AND stay there.

823+ Documents

Approved in the EU

100% success rate

Our Testimonials

Our Story

You can always feel when someone is truly frustrated.

Ed, my Father, was sitting across from me at dinner on a warm summer evening. And the stress was dripping off of his face. This was a few years back, but I can still feel it.

The topic of discussion tonight? Work, like usual. Ed had spent weeks reading the latest reg, EU MDR and preparing a presentation for the higher-ups that detailed his multi-year plan for compliance.

At the time, he worked for a massive manufacturer that had a portfolio of hundreds of SKUs, and was notorious for cutting corners. The day of regulatory reckoning was fast approaching, and Ed was adamant about revamping the CER team, the literature review process (that didn’t even exist for 90% of their tech files), and the plan for how to get these things written on time.

He laid it all out for his bosses, a full plan of attack complete with processes, hiring lists, and budgets. All in meticulous, yet easy to digest detail.

Can you guess what happened next?

They completely ignored him. Yep, that’s right. The ultimate decision was ‘let’s punt on this and see how strict they end up being with MDR’. Thanks for the powerpoint, Ed. Back to work.

There are two types of approaches to regulatory affairs and device compliance. The first approach is what was causing Ed so much stress. Where device compliance is an afterthought, a series of bureaucratic hoops to jump through, an anchor wrapped around the budget of big companies who need to ‘cut costs this quarter’.

The second approach is one of thought and precision. It takes a special kind of person to see the true art and benefits to medical writing. A dedication to getting the details right is vital, but above all else one must actually care.

So, you came to this page to see what our company was about? Well, It’s pretty simple.

We care about producing documents that matter for your devices. Whether it’s a CER, or a systematic literature review to shore up your EU MDR Technical file, we are on a never-ending quest to find the perfect process, the most dedicated and well-trained staff, the most state-of-the art software tools.

If you came looking for a chop shop with an army of faceless contractors, then I’m sorry but that’s not our thing.

If you’re looking for a partner who’s not afraid to get into the trenches with you and do the hard work, but also has the seasoned experience to advise and direct…then we should talk.

Our Reviews

Sylvia Wilkinson

Sylvia Wilkinson

Director, RA and QA

The timelines and level of service I got from CiteMed exceeded all expectations.

Channel Medsystem

Channel Medsystem

Director, Clinical and Regulatory Affairs

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.

Haleema Ahmed

Haleema Ahmed

International Regulatory Affairs Specialist

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.

Chris Slaymaker

Chris Slaymaker

General Manager, Healthcare

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

Chris Slaymaker

General Manager, Healthcare

I felt that the pricing was fair for the amount of work involved.

Circa Scientific

Circa Scientific

Quality Assurance Manager

The deliverables captured the whole requirements of the EU MDR regulations.

Sylvia Wilkinson

Sylvia Wilkinson

Director, RA and QA

CiteMed is very fun! They’re very self starting, self efficient…CiteMed could take it and run with it!

Channel Medsystem

Channel Medsystem

Director, Clinical and Regulatory Affairs

[CiteMed] was very responsive and adherent to the timeline we had all agreed upon. It was excellent!

Circa Scientific

Circa Scientific

Quality Assurance Manager

It allowed us to keep within our budget for regulatory expenses, without having to stop selling in Europe, basically!

Why Us?

  1. We meet your deadlines (5 week CERs)
  2. VIP customer service
  3. Guarenteed approval with free audit review hours
  4. You get peace of mind

Medical Writers Experience

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Our Team is Global
Your On Demand CER Writing Team

15+ Staff Writers and Regulatory Experts

6 Continents

5 Dedicated Project Managers

Depending on the size of your team, your needs will vary when it comes to the labor intensive CER process.

We’ve built a flexible and hybrid model here. Our team can handle the entire process end to end for you (full CER delivered with a bow on it) or we can collaborate with you as needed and simply provide guidance and support.

Literature Reviews and Post Market Surveillance (Vigilance Reports, PSURs and more) you’re welcome to handle internally, however in most cases we find that our team so is so efficient it’s cheaper and easier to leave it to them.

Citemedical Team

Our Team
Your On Demand CER Writing Team

15+ Staff Writers and Regulatory Experts

6 Continents

5 Dedicated Project Managers

Depending on the size of your team, your needs will vary when it comes to the labor intensive CER process.

We’ve built a flexible and hybrid model here. Our team can handle the entire process end to end for you (full CER delivered with a bow on it) or we can collaborate with you as needed and simply provide guidance and support.

Literature Reviews and Post Market Surveillance (Vigilance Reports, PSURs and more) you’re welcome to handle internally, however in most cases we find that our team so is so efficient it’s cheaper and easier to leave it to them.

Citemedical Team

Our Expertise
All Device Classifications in Europe/UK and the US

Our team’s experience is substantial. Together we have worked on devices across all classifications, with nothing but successful MDR submissions to show for our efforts.

For a full list of devices we’ve helped take to market with CER and PMS, please drop us a line and we’re happy to share.

Our Expertise
All Device Classifications in Europe/UK and the US

Our team’s experience is substantial. Together we have worked on devices across all classifications, with nothing but successful MDR submissions to show for our efforts.

For a full list of devices we’ve helped take to market with CER and PMS, please drop us a line and we’re happy to share.

Our Tools
Systematic Literature Review Software for Medical Device

We couldn’t operate as fast or as accurately as we wanted with Distiller, so we built our own systematic literature review platform.

Designed exclusively for medical device literature reviews (that will meet the MDR standards of course), our platform requires no initial setup, and can have you cranking out your own systematic literature review in an afternoon.

Learn more about our Systematic Literature Review Software here.

Our Tools
Systematic Literature Review Software for Medical Device

We couldn’t operate as fast or as accurately as we wanted with Distiller, so we built our own systematic literature review platform.

Designed exclusively for medical device literature reviews (that will meet the MDR standards of course), our platform requires no initial setup, and can have you cranking out your own systematic literature review in an afternoon.

Learn more about our Systematic Literature Review Software here.

Ace your audit without breaking a sweat.

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Stay in touch with us to get latest news and special offers.

Ace your audit without breaking a sweat.

Subscribe to our newsletter
Stay in touch with us to get latest news and special offers.