EU MDR Clinical Evaluation Document Reviews

Expertise Within Reach

A Clinical Evaluation Expert at Your Side

At Cite Medical, we understand the hurdles small medical device manufacturers and regulatory affairs specialists face with the transition to the new EU MDR regulations. Budget constraints should not be a barrier to accessing expert guidance.

Our service is tailored to empower the smaller entities in the medical field, ensuring they can confidently navigate these regulatory waters without the corporate price tag.

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

Get Your Clinical Evaluation Documentation Verified by Experts

Time is of the essence in the regulatory landscape. Our promise to you: fast turnaround times without compromising on thoroughness. Your work will undergo a detailed expert review, ensuring it stands up to the rigorous demands of EU MDR compliance.

Expertise That Fits Your Budget Quality Reviews, Unmatched Value

Leveraging our deep understanding of EU MDR requirements, we offer comprehensive reviews conducted by seasoned professionals. Our service is designed to fit the financial framework of smaller operations while maintaining the highest standard of regulatory scrutiny.

Proven Success and Efficiency

100% Success Rate

Our confident guarantee of success is backed by selective client partnerships and comprehensive support throughout the audit process.

Expedited Timelines

Experience industry-leading timelines, with the possibility of a 5-week turnaround for urgent needs.

Dedicated Expertise

Our dedicated writing team is experienced, qualified, and diverse, meeting all Notified Body and EU standards.

How It Works

Step 1. Send Your Documents

Deliver us your documents and let us get to work! Usually enough info is discussed on the intro cal lfor our team to understand your device, and situation.

Step 2. We Review

Our team combs through your documents with a (virtual) magnifying glass, and highlights all potential risks and issues with our 12 Step Review rubric.

Step 3. Discuss Your Report

We deliver your marked up documents along with a concluding report summary, and set up a call to review them and answer your questions.

The Risk of Non-Compliance: Don’t Gamble With Your Future

Ensure Your Documentation Meets the Mark

The cost of non-compliance goes beyond monetary penalties—it can disrupt your business and delay market entry. Partnering with us means placing your trust in a team that prioritizes your product’s journey, mitigating risks every step of the way.

Connect with Us: Take the First Step Towards Hassle-Free Compliance

Your Commitment to Innovation Deserves Expert Backing

Take action today. Contact us for a consultation and see how our clinical evaluation document review service can streamline your compliance process. It’s time to focus on what you do best: innovating in healthcare, while we ensure your documentation is in expert hands.

Have Questions?

Contact us to learn more about how our solution can be your cornerstone in EU MDR and IVDR compliance. Your commitment to healthcare excellence deserves a compliance process that reflects the same level of care and precision.

Let’s make it happen together.

Contact Us