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Proven EU MDR Templates for: SLR CER PMS PSUR

Over 500 successful submissions with our templates
Get to market and stay there, with peace of mind

Start Your MDR Project With Confidence

Anyone who has been in Regulatory Affairs for awhile knows that there is what the Regs say, and then what actually works in audits.

Over the past few years of successful MDR submissions, we have mastered both, and want to share what we’ve learned with manufacturers who are starting their MDR journey.

Save yourself some time and uncertainty by using the same (constantly updated) documents our writing team has used to collectively author and submit 300+ tech files.

Craft the perfect Systematic Review

Learn how to build and define search terms for your device.

How to choose data bases and classify articles

How to determine exactly which Databases need to be searched for the best results with your device. And get an exact decision-tree for how to read, classify, and interpret your search results.

Our Process Gets Approved

We have never had our process scrutinized or rejected by a Notified Body for concerns of thoroughness, quality, or adherence to current regulations.

All things clinical evaluation and surveillance

Our consulting clients have often found this to be the muddiest part of the MDR. Our templates take all of the guess work out and stop you wading in mud

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Start With Certainty

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Save Time By Starting Right

Let your RA staff focus on the content that they know. With the structure set in place and annotations to guide you to a completed document.

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Everything Included

Don’t risk missing/forgetting anything for your first submission. Our Templates include everything you need for an EU MDR Audit

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Updated Continuously

We constantly submit our own Templates, and update them based on the latest feedback from Notified Bodies.

Start With Certainty

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CER Explorer package:

    • .Docx Clinical Evaluation Protocol
    • .Docx Clinical Evaluation Protocol
    • .Docx Systematic Literature Review Report
    • .Docx Clinical Evaluation Report
PRICE: $597

+ Additional Taxes may apply

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CER Tour Guide package:

    • All CER Templates in Explorer package
    • Guidance documentation with Comments added to CER templates explaining each section
    • A worked example for reference
    • Annual updates for 1 year
PRICE: $597

+ Additional Taxes may apply

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CER All Inclusive:

    • All in Tour Guide package
    • 1 year access to our proprietary citmed.io SLR software
    • 5 hours of free consultation with an expert writer
    • A high five upon approval
PRICE: $2997

+ Additional Taxes may apply

Looking for Full Service?

If your team is already stretched too thin Citemedical can hand you NB ready documentation.
Our clients love our: Speed | Quality | customer service

Stuck on EU MDR Post Market Surveilance?

PMS Explorer package:

  • .Docx Post Market Surveillance plan
  • .Docx Post Market Clinical Follow Up Plan
  • .Docx Vigilance report
  • .Docx Periodic Safety Update Report
  • .Docx Post Market Clinical Follow up Report
PRICE: $197

+ Additional Taxes may apply

PMS Tour Guide package:

  • All Templates in Explorer package
  • Guidance documentation with Comments added to templates explaining each section
  • A worked example for reference (includes Survey Template)
  • Annual updates for 1 year
PRICE: $597

+ Additional Taxes may apply

PMS All Inclusive:

  • All in Tour Guide package
  • 8 hours of free consultation with an expert writer
  • A high five upon approval
PRICE: $2997

+ Additional Taxes may apply

Not seeing exactly what you’re after?

Looking for other templates, training packages. Want a deal on CER and PMS templates, hit the button below Or If your team is already stretched too thin Citemedical can hand you NB ready documentation. Our clients love our: Speed | Quality | customer service

Book a call today

The questions we hear most often

The platform covers various processes and roles, so questions can vary from security to integration. We have collected short answers to the questions most teams are interested in at the start

Yes! Much more than templates. Our guide package includes complete instructions detailing out every aspect of the review. You will not need any other instruction to conduct, write, and complete your Literature Review.

Visit my linkedin to get some clarity on broad questions you may have. If you need detailed, expert support see our inclusive packages where we offer 1 to 1 advice with a clinical evaluation expert.

Only the Inclusive package does. This process and templates are designed to be conducted entirely on your own and no use of our software is required. If you would like to speed things up further, contact us to test drive our software.

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