Your EU MDR Lifeline
Has Arrived

100% Success Rate Submission Work – On a tight timeline!

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What Do You Need?

I need audit support, yesterday!

Book a Call

I have questions, or want an expert review of my documents before I submit

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I’m looking for general writing and support

How It Works

We go over your project

(15-20 Minutes) is usually all it takes to understand your situation, and give you some ideas on strategy/pricing.

We review your documents and send a proposal

(1-2 Days) If aligned on strategy, we’ll take a deeper dive into your documents, and prepare a plan of action, complete with timeline and pricing.

We deliver

(TBD) Our team boasts lightnening fast turnaround on all MDR project types if you’re facing a tight timeline or a tricky auditor.

A Track Record You Can Bet On

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

Experienced Staff On-Demand

35+ Years of Total Experience

in Drug and Device Development

Job Experience

Vice President, Clinical Quality Assurance

Director of Good Clinical Practice

Education

M.Sc. Biochemistry

B.A., Biology, Chemistry

Major MDR Docs authorized: 250+ Docs

CEP, LITP, LITR, CER, PMSP, PMSR, PSUR, PMCFP, PMCFR, SSCP, Technical File, Risk Management Files, PER, SVR
11+ Years of Total Experience

in Scientific Writing, Research and Teaching

Job Experience

Deputy General Manager

Scientific Writing Lead

Education

PhD (Microbiology)

Major MDR Docs authorized: 280+ Docs

CEP, LITP, LITR, CER, PMSP, PMSR, PSUR, PMCFP, PMCFR, SSCP, CPR, SVR, Clinical Narratives
6+ Years of Total Experience

in Scientific Writing and Research

Job Experience

Manager of Value Evidence Outcomes Consultant (Medical Devices | CER | MDR | SLR | HEOR)

Senior Medical Writer (Medical Devices | CER | MDR)

Education

M.Ps in Pharmaceutics: Preparation and optimization of valsartan bilayered substained release matrix tablets'

Major MDR Docs authorized: 50+ Docs

CEP, CER, PMS, PSUR, SLR (medical devices), PEP, PER, (IVD
5+ Years of Total Experience

in Scientific Writing and Research

Job Experience

Subcontract - Medical Writer

Program Lead - QMS

Engineer - Quality & Regulatory Affairs

Education

PGDM, Fermentation & Bioprocessing

M.Sc Microbiology

Major MDR Docs authorized: 70+ Docs

CEP, LITP, LITR, CER, PMSP, PMSR, PSUR, PMCFP, PMCFR, SSCP, Technical File, Risk Management Files
3+ Years of Total Experience

in Scientific Writing and Research

Job Experience

Freelance Medical Writer and Editor

Senior Regulatory Affairs Specialist

Education

Professional Diploma in Medical Writing

M.Eng in Biology

Major MDR Docs authorized: 30+ Docs

CEP, LITP, LITR, CER, SOTAR, MRR, PMSR
6+ Years of Total Experience

in Scientific Writing and Research

6+ Years of Experience

in the Drug Safety, Clinical Trials, Narrative Writing

Job Experience

Senior Technical Lead (Senior Medical Writer) (Medical Device - CER)

Senior Medical Writer/Lead (CER Writer)

Education

M.Ba in Allied Health Science

M.Sc Microbiology

Major MDR Docs authorized: 40+ Docs

CEP, CER, PMCF Plan, PMCF Report, PMS Plan, PMS Report, PSUR

The Ten Most Common MDR
Non-Conformity Mistakes

(and how to fix them)

For manufacturers looking to strengthen their Clinical Evaluation and Post Market Surveillance related documents and sail through their Audits.

We’ve seen more than enough Notified Body feedback to last a lifetime. This report is a summary of our findings, and how to address them.

Download the Report

EU MDR Problems We Solve

What are you waiting for?

Whether you’re up against it with your submission or still in the information gathering phase, speaking with one of our experts can only help (and it’s free).

Get in Touch Today

Your EU MDR Lifeline Has Arrived

What Do You Need?

I need audit support, yesterday!

I have questions, or want an expert review of my documents before I submit

I’m looking for general writing and support

How It Works

A Track Record You Can Bet On

Experienced Staff On-Demand

11+ Years of Total Experience in Scientific Writing, Research and Teaching Job Experience Deputy General Manager Scientific Writing Lead Education PhD (Microbiology) Major MDR Docs authorized: 280+ Docs CEP, LITP, LITR, CER, PMSP, PMSR, PSUR, PMCFP, PMCFR, SSCP, CPR, SVR, Clinical Narratives

3+ Years of Total Experience in Scientific Writing and Research Job Experience Freelance Medical Writer and Editor Senior Regulatory Affairs Specialist Education Professional Diploma in Medical Writing M.Eng in Biology Major MDR Docs authorized: 30+ Docs CEP, LITP, LITR, CER, SOTAR, MRR, PMSR

The Ten Most Common MDR Non-Conformity Mistakes

(and how to fix them)

EU MDR Problems We Solve

Audit Feedback and Non-Comfority Correction

CER Drafting, Updating, Reviewing

Gap Assessment, and ‘Audit Readiness’ Reviews

Post Market Surveillance and Clinical Follow-Up

MD Clinical Reviewer

What are you waiting for?

Whether you’re up against it with your submission or still in the information gathering phase, speaking with one of our experts can only help (and it’s free).

Your EU MDR Lifeline
Has Arrived

The Ten Most Common MDR
Non-Conformity Mistakes

CER Drafting, Updating,
Reviewing